Wednesday, 19 April 2017

CE Marking and RoHS Certification for LED Lights

CE Marking and RoHS Certification


Are you looking for CE Certification and RoHS Certification Service for your LED Products?

Then you’re at the right place. Eurotech One of the Best CE Certification Body in India, offer you CE Marking and RoHS Certification for your LED Lighting Products. On this Blog, we are not just going to pitch you to Choose us for CE Certification, Our CE Marking Experts will provide you lots of valuable information on CE Certification, what, why and how to do CE Marking Certification and RoHS Certification on your LED Lights.

What do CE Marking Certification Mean?

CE Marking Certification is necessary for many products to get the CE Marking Certification to enter the European market. If a product is CE Marked, it means that it fills all the norms of European health, safety & environmental directives arrange by the related legislation. Even the foreign companies must get their manufactured products CE Marked in order to sell them in the European markets without any review.
The EU has a raft of Directives which specify the health, safety and environmental requirements for many Equipments offered for sale in the European market, regardless of origin. To show they meet these standards, Equipments carry the CE Certification label. These Directives form a complex web of legislation. Import, Export, Suppliers and Manufacturers are obliged to show how their Equipments meet the standards.
All easily LED Light range of LED bulbs, such as the B22 LED, the GU10 LED, and the E14 LED, carry the CE Certifiction and conform with all the current European Union Directives.

What do RoHS Certification Mean?

RoHS Restriction of Hazardous Substances Directive Certification - Regulatory authorities are recommend new ways to reduce the environmental impact & potential hazard of wastes from electrical products . The European directive on the RoHS holds electrical and electronic products companies directly answerable for the chemical compliance of their products. This means all Equipments have to comply to strict standards, extensive compliance documentation & ensure that electrical & electronic Equipments sold in the European Union don’t contain lead, cadmium, mercury, hexavalent chromium, PBBs, & PBDEs above the legal opening.
RoHS is Restriction of Hazardous Substances Directive, the RoHS Restriction of Hazardous Substances Directive forms part of the EU legislation designed to take care of human beings and the environment. The Directive restricts the use of certain hazardous substances such as lead and mercury in the build of electrical and electronic devices on sale in the European Union.
It is closely linked with WEEE Waste Electrical and Electronic Equipment Directive – where RoHS Restriction of Hazardous Substances Directive applies to  Producting, WEEE applies to recycling.
Products for sale in the European Union must comply with the RoHS Restriction of Hazardous Substances Directive standards, and maker must maintain extensive compliance documentation.
As well as conforming to the CE Certification Directive, all LED bulbs in the easily LED range meet the RoHS Restriction of Hazardous Substances Directive standards.  From strip light LED lights through to the E27 LED wide screw, you can be sure easily LED bulbs comply with the highest standards in today’s energy-efficient lighting market.

Please note the CE certification charges as below:

Product: LED lights and European Plug Adapter
Applicable directive: Low voltage directive 2014/35/EU and Electromagnetic compatibility directive 2014/30/EU
Applicable standards: IEC 61347-2-13, IEC 60598-1 , Application , registration , assessment & certification charges : INR 70,000/-
Safety testing charges of Adaptors IEC 61347-2-13: INR 45,000/- per model
Safety testing charges of LED light as per IEC 60598-1: INR 40,000/- per model
EMC testing charges: INR 25,000/- per model
Validity of certificate: 5 yr
Taxes and TBL of auditor extra @ actual
2) ROHS certification charges: INR 60,000/- per product (including testing charges)
Our CE certification charges is inclusive of audit , testing from NABL approved lab , documentation guidance and certification from our UK based certification company Eurotech.

People also ask:

If Your Buyers Demanding for CE Marking Certification – Contact Now!

Kindly send us the following Details, So that we can provide you quotation for the same.

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

CE Certification Specialists - Free 24 Hour Advice & Support

Submit your requirement for "CE Certification Services"
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com
Get Instant Quotation! Please complete the Enquiry form below:

Thursday, 30 March 2017

Need CE Certification?

Need CE Certification?
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Need CE Marking Certification?


Buyers Demanding for CE Certification Services - Contact Now! 08196980555
Kindly Share Your Requirements with product Technical Specification,
Get Free Quote  https://goo.gl/CyVHMs https://goo.gl/1IKJaj
Puneet Sharma | E-mail: CE.Marking.Certification@Gmail.Com

#Need #CE #Marking #Certification #Notified #Body #Ahmedabad #Mumbai #Delhi #Mohali #Chennai #UK #USA #Canada #Ireland #ITCIndia #Eurotech

Friday, 13 January 2017

CE Mark Certification and Testing Service


CE Mark Certification and Testing Service provider in India

Eurotech Certification Body offer CE Mark Certification in India, which is also known as CE Marking. This is a mandatory conformance mark on many products to be placed in European market, which make secure that the product is in compliance with the important demands of the applicable EC directives. If a product has slightest risk it can be self certified where the manufacturer prepares a declaration of conformity and the CE Marking is tag to a product by the manufacturer or authorized representative

List of CE Marking Directives:

  • Active implantable medical devices 90/385/EEC
  • Airborne noise
  • Appliances burning gaseous fuels 2009/142/EC
  • ATEX 94/9/EC
  • Cable way installations for persons 2000/9/EC
  • Construction products 89/106/EEC
  • Conventional rail
  • Dangerous substances
  • EMC 2004/108/EC
  • Explosives for civil uses 93/15/EEC
  • General product safety 2001/95/EC
  • High-speed rail 96/48/EC
  • Hot-water boilers 92/42/EEC
  • In vitro diagnostic medical devices 98/79/EC
  • Lifts 95/16/EC
  • Low voltage 2006/95/EC
  • Machinery 2006/42/EC
  • Marine Equipment 96/98/EC
  • Measuring instruments 2004/22/EC
  • Medical devices 93/42/EEC
  • Packaging 94/62/EC
  • Personal protective equipment 89/686/EEC
  • Postal Services
  • Pressure equipment 97/23/EC
  • Pyrotechnic articles 2007/23/EC
  • Recreational craft 94/25/EC
  • R&TTE 1999/5/EC
  • Simple pressure vessels 2009/105/EC
  • Toys 2009/48/EC
  • Weighing Instruments 2009/23/EC

Eurotech Provide CE Marking Certification in various cities of India:

  1. CE Marking Certification in Delhi
  2. CE Marking Certification in Mumbai
  3. CE Marking Certification in Kolkata
  4. CE Marking Certification in Hyderabad
  5. CE Marking Certification in Surat
  6. CE Marking Certification in Visakhapatnam
  7. CE Marking Certification in Ghaziabad
  8. CE Marking Certification in Chennai
  9. CE Marking Certification in Ahmedabad
  10. CE Marking Certification in Bangalore
  11. CE Marking Certification in Pune
  12. CE Marking Certification in Jaipur
  13. CE Marking Certification in Rajkot
Other details:
CE Mark does not signify that a product was built in the European Economic Area (EEA), but hardly states that the product is assessed before being established on the market and thus satisfies the legislative needs (e.g. a harmonized level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential needs (e.g. safety, health, environmental protection needs) of the applicable directives – or, if stipulated in the directives, has had it checked by a notified. CE Mark is a key signal of a product’s compliance with European Union law and authorizes the free movement of products within the European market. CE Mark approve that a product satisfies the legislative needs, e.g. a harmonized level of safety, to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential needs, e.g. health and safety needs, of the applicable directives or, if stipulated in the directives, had it examined by a notified conformity assessment body.

If Your Buyers Demanding for CE Marking Certification – Contact Now!

Kindly send us the following Details, So that we can provide you quotation for the same.

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

Submit your requirement for "CE Certification Services"
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com
Get Instant Quotation! Please complete the Enquiry form below:

Submit your requirement for Testing:-
Full Name

E-mail:

Describe Your Requirements with Technical Details:






Thursday, 4 August 2016

CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed India

CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed in India


CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed in India

CE Marking for Valve Plate, CE Marking for Cushion Plate, CE Marking for Spring Plate, CE Marking for Valve Reed in India, Mumbai, Ahmedabad, Delhi, Chennai, Chandigarh, CE Marking for Valve Plate, what products need ce marking, ce marking self certification, ce marking exemptions, ce marking low voltage directive, ce marking requirements pdf, ce marking prototypes, ce marking one off products, ec new approach directives guidance
If you are looking CE Marking Certificate for Valve Plate, Cushion Plate, Spring Plate, Valve Reed, If your client Demanding For CE Marking, or If you want to Export your product in European countries. Eurotech Can Help you! Eurotech One of the Best Certification body Providing CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed.
CE Marking Certification Expert Providing CE Marking Certification service on Valve Plate, Cushion Plate, Spring Plate, Valve Reed as per General Product Safety Directive (CE Mark-GPSD)

Kindly send us the following Details, So that we can provide you quotation for the same.

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

If Your Buyers Demanding for CE Marking Certification – Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com
Get Instant Quotation! Please complete the Enquiry form below:


Full Name


E-mail:


Describe Your Requirements with Technical Details:


CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed India

CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed in India


CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed in India

CE Marking for Valve Plate, CE Marking for Cushion Plate, CE Marking for Spring Plate, CE Marking for Valve Reed in India, Mumbai, Ahmedabad, Delhi, Chennai, Chandigarh, CE Marking for Valve Plate, what products need ce marking, ce marking self certification, ce marking exemptions, ce marking low voltage directive, ce marking requirements pdf, ce marking prototypes, ce marking one off products, ec new approach directives guidance
If you are looking CE Marking Certificate for Valve Plate, Cushion Plate, Spring Plate, Valve Reed, If your client Demanding For CE Marking, or If you want to Export your product in European countries. Eurotech Can Help you! Eurotech One of the Best Certification body Providing CE Marking for Valve Plate, Cushion Plate, Spring Plate, Valve Reed.
CE Marking Certification Expert Providing CE Marking Certification service on Valve Plate, Cushion Plate, Spring Plate, Valve Reed as per General Product Safety Directive (CE Mark-GPSD)

Kindly send us the following Details, So that we can provide you quotation for the same.

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

If Your Buyers Demanding for CE Marking Certification – Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com
Get Instant Quotation! Please complete the Enquiry form below:


Full Name


E-mail:


Describe Your Requirements with Technical Details:


Monday, 1 August 2016

CE Mark Certification In 5 Steps | Gain Access to the European Market

CE Marking Certification in Five Steps | Gain Access to the European Market

If your Buyers Demanding for CE Marking Certification in India, Or If you want to export your product in European Countries or if looking for CE Certification Consultancy Services. Eurotech Certification Body Providing an easy guidance of CE Marking certification to help manufacturers and exporters Get their product CE Mark
CE Mark Certification is a mandatory legal conformity requirement for all products sold within the EU that fall within the scope of a CE mark directive. By affixing a CE Mark logo to a product and signing the Declaration of Conformity, a product supplier is declaring to the EU European Union authorities that the requirements of all applicable directives have been met. Depending on the directive, involvement of a EU (European Union) NB (Notified Body) may be mandatory or voluntary.

CE Marking Certification in Five Steps:

  1. Decide which Directives are applicable to your product
  2. Ensure your product is compliant with the applicable Directives by testing and apply the relevant conformity assessment procedures
  3. Compile and retain a technical file, which satisfies the requirements of the Directives
  4. Write and sign the Declaration of Conformity and keep the original with the technical file
  5. Apply CE marking to the equipment in accordance with the requirements of the Directive
CE Marking Certification is a mandatory legal conformity requirement for all products sold within the EU that fall within the scope of a CE Marking Certification Directive. By affixing a CE Marking Certification to a product and signing the Declaration of Conformity, a product supplier is declaring to the European Union authorities that the requirements of all applicable directives have been met. Depending on the directive, involvement of a EU Notified Body may be mandatory for certain types of products.
Eurotech Certification Body assists companies to demonstrate their products compliance with the requirements of applicable Directives, by offering testing & certification in line with these requirements.

CE Marking EU European directives:-

CE Marking EU Directives for Electricals, Electronics and Consumer Products:

  1. CE Marking LVD Low Voltage Directive (2006/95/EC)
  2. CE Marking Electromagnetic compatibility (EMC) Directive 2004/108/EC
  3. CE Marking Radio Equipment Directive (RED) Directive 2014/53/EU
  4. CE Marking R and TTE Directive 1999/5/EC (Radio and Telecommunication Terminal Equipment)
  5. CE Marking Energy-related Products ERP Directive 2009/125/EC
  6. CE Marking Toys Safety Directive 2009/48/EC
  7. CE Marking RoHs 2011/65/EU (Restriction of Hazardous Substances Directive)

CE Marking EU European directives for Machinery and Equipment:-

  1. CE Marking Machinery Directive 2006/42/EC
  2. CE Marking ATEX Directive 94/9/EC
  3. CE Marking Construction Products Regulation 89/106/EEC

CE Marking Medical Devices EU European directives:-

  1. CE Marking Active Implantable Medical Devices Directive 90/385/EEC
  2. CE Marking In-Vitro Diagnostics Directive 98/79/EC
  3. CE Marking Medical Devices Directive 93/42/EEC

If Your Buyers Demanding for CE Certification Services - Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com

Get Instant Quotation! Please complete the Enquiry form below:


Full Name


E-mail:

Describe your Requirements:








Tuesday, 19 July 2016

FSC Free Sale Certificate | Free Sale Certificate Medical Device India

FSC Free Sale Certificate India, FSC Free Sale Certificate, Free Sale Certificate Medical Device India

If you are looking for FSC Free Sale Certification service in India, Eurotech Certification Body can Help you! Eurotech one of the Best FSC Free Sale Certification Consultant in India, if your Buyers Demanding for FSC Free Sale Certificate, you can feel free to contact us. Call: 08196980555
Free sale certificate is basically a document for certain commodities like pharmaceuticals required in certain countries. This document particularly specifies the certification that the imported goods are normally & freely sold in the exporting country's open markets and are approved for export.
The WHO induced certification for Free sale certificate scheme on the quality of pharmaceutical products so that the imported pharmaceutical products should encounter a trust of safety, effectiveness & adequate quality.
Usually WHO certification scheme includes good practices in the manufacture & Quality control of drugs.
Free Sale Certificate Scheme should enroll UPTO date list of manufacturers complying with GMP by the exporting countries.
Health Authorities of exporting countries must have the issuance of batch certificate.

There are various WHO type certificate which includes:

  • Certificate of pharmaceuticals WHO (1975)
  • Certificate of pharmaceuticals WHO (1988)
  • Certificate of pharmaceuticals WHO (1992)
  • BATCH Certificate etc.

Sually FREE SALE CERTIFICATE processes various procedures:

Example: If any country wants to export any item like any food material so it should follow these processes:
Rural payment agency should produce certificates like is it suitable for human consumption and animal consumption as well.
Human consumption must provide assurance that the product they are exporting should be safe and approved. It should not provide any harmful effects on the health.
For Animal consumption again assurance must be there in order to provide product free from radioactive elements.
Several Requirements must be followed in order to attain certification of Free sale Certificate:-
Companies must submit copies of invoices showing the sale of each product so that if in future any problem arises due to any circumstances there must be a proper submission of copies.
Manufacturer must given a written declaration to prove that its product is safe, secured and approved.
Specification of country name must be there so that no problem could be raised in future.

Documents which need to be submitted for the FSC are:

Check or verification of payment, unless a credit on account facility has been set up with the HPRA.
Proof of manufacture in the form of a notarized document.
Subsequent changes to the product listing do not need to be notarized.
 A copy of the current notified body certificates for the relevant devices.
Applications of this free sale certificate include a Secretary who can issue export certification for goods for therapeutic use in humans with the guarantee of safe and approved products.
Sometimes inspection programs are conducted in this to inspect any mistake or doubt and in return it is good program to check whether all the things that are listed must be correct.
Validity for Free Sale certificate must be included as an important part and it is 5 years from the date of issue.
Free Sale Certificate is basically a good option for the imported countries as what they want to have they can demand with proper certification and safe sight approval.

If Your Buyers Demanding for FSC Free Sale Certification Services - Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: Meddevices.net@Gmail.com

Get Instant Quotation! Please complete the Enquiry form

all Us On0896980555

Friday, 15 July 2016

CE Marking Certificate for Orthopaedic products

CE Marking Certification for Orthopaedic Products in India

CE Marking Certification for Orthopaedic Products in India

If you are looking CE Marking Certificate for Orthopaedic products, If your client Demanding For CE Marking Certification, or If you want to Export your product in european countries. Eurotech Can Help you! Eurotech One of the Best Certification body Providing CE Marking Certification for Orthopaedic products.

Kindly send us the following Details, So that we can provide you quotation for the same.

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

If Your Buyers Demanding for CE Marking Certification – Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: CE.Marking.Certification@Gmail.com
Get Instant Quotation! Please complete the Enquiry form

Wednesday, 6 July 2016

11 Steps in the US FDA Medical Device Approval Process | US FDA Registration Process for Medical Devices India

US FDA Registration Process for Medical Devices

Eurotech And Meddevices Certification Body Providing US FDA Certification and Registration service in India. If your client Demanding for US FDA Certification Registration, you can feel free to contact us.
All The Manufacturers, Traders, Suppliers, Exporters companies planning to sell a Medical Devices in the United States of America need to register their product with the US FDA Registration. Most Class 1 devices can be self-registered but most Class 2 devices require a 510(k) submission. For Class 3 devices, a Pre-Market submission is needed. The steps below provide a brief overview of how the PMA & (Food and Drug Administration) FDA 510(k) process work. The chart shown illustrates the (Food and Drug Administration) FDA approval process in USA.

Step 1 US FDA Medical Device Approval Process

Using the (Food and Drug Administration) FDA classification database, determine the classification of your device by researching Predicate Medical Devices already registered in the US market. Pay special attention to the three letters Device/ Equipment Code and 7 digits Regulation Number associated with the predicate Medical Equipment you identify. If no predicate found, use 513(g) / De Novo process. US FDA Medical Devices classification is made up of Class I, Class II and Class III.

Step 2 US FDA Medical Device Approval Process

Implement QMS which meets the (Food and Drug Administration) FDA Quality System Regulation found in 21 CFR Part 820. This is also commonly known as (Food and Drug Administration) FDA GMP.

Step 3 US FDA Medical Device Approval Process

Innovative Class II, and all Class III, Medical Devices will likely require clinical studies. Get Pre-Submission feedback from the (Food and Drug Administration) FDA.

Step 4 US FDA Medical Device Approval Process

If clinical studies will be required, apply for an Investigational Device Exemption. Develop clinical trial protocol and conduct studies.

Step 5 US FDA Medical Device Approval Process

For Class II Medical Devices, prepare & submit 510(k) Pre-market Notification application. Pay 510(k) / PMA submission fee. For Class III Medical Devices, prepare & submit Premarket Approval application. Pay PMA submission fee to (Food and Drug Administration) FDA.

Step 6 US FDA Medical Device Approval Process

For Class III Medical Devices, (Food and Drug Administration) FDA conducts facility inspections of all major Manufacturers /suppliers/ Exporters involved in the design & production of your Equipment. All parties must be compliant with (Food and Drug Administration) FDA QSR.

Step 7 US FDA Medical Device Approval Process

For Class II Medical Devices, the FDA (Food and Drug Administration) issues 510(k) clearance letter & posts it online. For Class III Medical Devices, the FDA (Food and Drug Administration) FDA issues PMA approval letter & posts it online.

Step 8 US FDA Medical Device Approval Process

At this time, you must be in full compliance with QSRs. The (Food and Drug Administration) FDA will not inspect Class I or II Medical device Manufacturers /suppliers/ Exporters for compliance prior to device registration but does conduct random inspections and can issue a Form 483 for non-compliance..

Step 9 US FDA Medical Device Approval Process

If you have no local presence in the US, appoint an (Food and Drug Administration) FDA US Agent representative as a local point of contact with the (Food and Drug Administration) FDA..

Step 10 US FDA Medical Device Approval Process

List your Medical Devices & register your company using FURLS system on the (Food and Drug Administration) FDA website in accordance with 21 CFR Part 807 contract /suppliers/ Exporters & sterilizers must also register & list. Specify your appointed US Agent. Your (Food and Drug Administration) FDA Establishment Registration and Listing must be renewed on a yearly basis.

Step 11 US FDA Medical Device Approval Process

You are now able to sell your device in the US. The FDA (Food and Drug Administration) listing on their website will serve as your authorization to commercialize your device in the US. This authorization does not expire as long as certain types of changes are not made, e.g., design, intended use.

Please give us the following information to quote you:

1. Name of product
2. Product photograph
3. Intended use of the product
4. Technical specification of the product.

If Your Buyers Demanding for US FDA Certification Registration Services - Contact Now!
Mr. Puneet Sharma | Call: 08196980555 | Email: Meddevices.net@Gmail.com

Get Instant Quotation! Please complete the Enquiry form below:

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