Albutec GmbH
DE-MF-000009769 · Germany · Rostock
Albutec GmbH is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 24 |
|---|
Among these devices, 16 are declared sterile.
Devices declared under this manufacturer
- Hepalbin-MaxiCycler1 deAir
- Hepalbin-MaxiCycler3 deAir
- Hepalbin-MaxiCycler5 deAir
- Hepalbin®-MaxiCycler1
- Hepalbin®-MaxiCycler3
- Hepalbin®-MaxiCycler4
- Hepalbin®-MaxiCycler5
- Hepalbin®-MaxiCycler7
- Hepalbin®-MaxiCycler8
- Holder For Dialyzers
- Holder For MC3-9
- Holder I For Infusion Pump
Showing 12 of 24 declared devices.
Catalogue references include 80005-1A, 80005-3, 80005-4, 80005-5, 80005-8, 80006-A.
European nomenclature codes declared: A0499,F0199, F9080, A0499, A040180,F9080.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 24 |
| 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 | 24 |
|---|---|
| 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. Albutec GmbH was not found in either the U.S. or the Canadian register.