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The Cyclo-ssage pro personal MK4 therapy system
OM7300IR-­MED
Berlin Cert - Product Certification

CE 0633

The Cyclo-ssage Pro Personal Mk4 Therapy System has been certified and approved by the Berlin Cert specialist laboratory as a tested medical product and has the medical conformity label CE 0633

Berlin Cert GmbH is a testing and certification agency in the center of Berlin, which originated from the testing agency for medical appliances at the Technical University of Berlin in 2001.They focus on mechanical and electrical testing of medical devices as well as the certification of products and quality management systems for manufacturers of medical devices.

 

Berlin Cert GmbH is accredited as a testing laboratory by ZLG (inactive health care products) and ZLS (active health care products). This means the results are recognized within Europe.

 

With regards to including products in the medical aids and appliances register (HMV) of health funds in Germany, they conduct the necessary product testing (for 13 of 30 HMV product groups) and are recognized as a specialised testing laboratory by the central association of health funds.

 

Why does a medical appliance need to be certified?

Certification of a product according to attachment IV of guideline 93/42/EEC is necessary for medical devices (except class I products) as part of the conformity assessment procedure as soon as the manufacturer has decided to have the product certified in an attempt to monitor its manufacture.

 

Who may have their products certified?

cert berlin

Berlin Cert may certify only medical appliances, which fall within the scope of the certification agency. At this point in time, this means only active medical appliances like devices used in surgery, stimulation appliances as well as most other medical appliances, excluding those active medical devices with ionizing rays.

Although Berlin Cert is based in a building of the Technical University of Berlin, it is independent and as a GmbH economically independent. However, for some projects and in the area of training, Berlin Cert and TU Berlin work in co-operation.

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