/// NEWS
2021 May 31
Approval at the Sugarloaf Mountain
Bioabsorbable MAGNEZIX® CBS approved for medical use in Brazil. >>
Quality made
in Germany -
certified in
Europe and
around the world
Tested safety
New technology is very fascinating, but it can also be viewed with skepticism in some cases. We understand this. Especially because it involves something of the very highest value - health. This is an area where no risks are acceptable and where all of those involved must be absolutely confident that they are doing the right thing.
The repeatedly assured and meticulously and continuously controlled quality is the minimum requirement which we wish to fulfill with our quality standards. For you, it is the precondition to enable you to use our implants without any concerns and with the certainty that you are doing the right thing.
We give you this assurance:
- CE-label tested and certified by TÜV.
- Approved throughout Europe, Singapore and another 20 countries as a medical product of the very highest safety and regulatory class (class III and/or class D).
- Certified pursuant to DIN EN ISO 13485 and according to medical product directive 93/42/EEC.
- The most stringent testing and documentation requirements for quality assurance on the basis of internal laboratory tests and external independent testing institutes.
- Safety and traceability of every implant from the production to the patient is guaranteed.
- Already successfully tried and tested thousands of times in hospitals.
MAGNEZIX® implants: international approvals
Belgium
Bulgaria
Denmark
Germany
Estonia
Finland
France
Greece
Greenland
Great Britain
Ireland
Italy
Croatia
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Austria
Poland
Portugal
Romania
Sweden
Slovakia
Slovenia
Spain
Czech Republic
Hungary
Cyprus
Andora
Iceland
Liechtenstein
Monaco
Norway
San Marino
Switzerland
Vatican City
Albania
Australia
Bangladesh
Botswana
Brunei
Chile
Ecuador
Hong Kong
Indonesia
Iran
Israel
Jordan
Qatar
Kenya
Kuwait
Macau
Malaysia
Mauricio
Mexico
Mozambique
Myanmar
New Zealand
Panama
Peru
Saudi Arabia
Singapore
South Africa
Turkey
Vietnam
Grün
CE-Approval and UK
Orange
EFTA and EU Microstates
dunkelgrün
National Approvals