Sartorius Stedim Biotech GmbH
DE-MF-000017607 · Germany · Göttingen
Sartorius Stedim Biotech GmbH is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 40 |
|---|
Most frequent device types declared: 16534----------K, 16555----------Q, 16596--------HYK, 17528----------K, 17594--------GUR.
Among these devices, 28 are declared sterile.
Devices declared under this manufacturer
- Minisart® HY
- Minisart® HY | SRP
- Minisart® NML
- Minisart® NML | Ophthalsart
- Minisart® Ophthalsart
- Minisart® SRP
Showing 12 of 40 declared devices.
Catalogue references include 16555----------K, 16555--------GUK, 16596--------HYK, 16596--------HYQ, 17594----------K, 17594--------GUR.
European nomenclature codes declared: A04010101, A04010102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 40 |
| 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 | 39 |
|---|---|
| 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. Sartorius Stedim Biotech GmbH was not found in either the U.S. or the Canadian register.