Bionic Medizintechnik GmbH
DE-MF-000012048 · Germany · Friedrichsdorf
Bionic Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Most frequent device types declared: KPA06004-4, KPA06006-4, KPA06047-1, KPA06048-1.
Among these devices, 7 are declared sterile.
Devices declared under this manufacturer
- AV Extension tubes
- Dialysis connection and disconnection sets
- Single Needle Adapter
Catalogue references include AV-EXT2, KPA06004-4, KPA06006-4, KPA06047-1, KPA06048-1, SNA3.
European nomenclature codes declared: F0399, F900301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Bionic Medizintechnik GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 015198 0034 | issued | 2031-08-12 |