Certification & International Approvals

Eurofins is your competent partner for national and international approvals and certification of telecommunication equipment, radio and wireless equipment and electronic devices, such as: household, entertainment, office and IT equipment. Eurofins is accredited as an independent certification body according to international standards and offers a wide range of certifications.

Certification by Eurofins strengthens the trust of your customers and gives you access to the most important markets worldwide.

Competences: 

• Notified Body according to European Radio Equipment Directive (RED) 2014/53/EU
• Notified Body according to EMC directive 2014/30/EU
• Admission Office for FCC (USA) as TCB (Telecommunication Certification Body) and ISED (Kanada) as FCB (Foreign Certification Body)
• Implementation of international approvals
• Certification Body in the context of the IECEE CB Process (NCB)

Registration Services:

• Worldwide authorisation of telecommunications equipment in e.g. Europe, Latin America, Asia, Australia, Africa, Russia, Japan
• Bluetooth® Qualification Service
• CTIA/PTCRB
• Blue Angel
• Technical service for E-Mark on behalf of the Federal Motor Transport Authority (KBA)

Certification of QM-Systems for Medical Devices

Eurofins Product Service GmbH is an accredited Certification Body for DIN EN ISO 13485.

We certify QM systems in the Scopes

Non-active medical devices

• General non-active non-implantable medical devices
  • Products for orthopaedics and rehabilitation
  • Non-energetic medical measuring equipment
  • Instruments

Active non-implantable medical devices

• General active medical devices
  • Devices for extracorporeal circuits, infusions and haemopheresis
  • Devices for stimulation or inhibition
  • Surgical devices and surgical auxiliaries
  • Rehabilitation devices and active prostheses
  • Patient positioning and transport equipment
  • Software - Monitoring devices
  • Devices for monitoring non-vital physiological parameters
  • Devices for monitoring vital parameters

Medical devices with/using specific materials/technologies

• Medical devices that are also machines within the meaning of Directive 2006/42/EC
• Medical devices containing, using or controlled by software

Parts and services

• Raw materials
• Semi-finished products
• Components
• Trade in medical devices
• Maintenance services

Custom-made products for the health care trade

• Non-sterile

In the field of

• Orthopaedic and orthopaedic shoe technology
• Rehabilitation technology

Conformance assessments in accordance with MDR (EU) 2017/745 are available for this and additional categories of active and non-active MedicalDevices as far as IVD-Devices through our global network of Eurofins service providers. Please contact us to find out how wecan help you gain global market access even if your product category is not listed above.

Contact Us:
+49 33631 888 801
EEinfoDE@eurofins.com