Hänsler Medical GmbH
DE-MF-000025903 · Germany · Iffezheim
Hänsler Medical GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 8 |
|---|
Among these devices, 1 are declared active.
Devices declared under this manufacturer
- HUMACOLON Darmrohr DR07
- HUMACOLON Darmrohr DR13
- OZONOSAN Catheter 18 Ch.
- OZONOSAN Dosing Bellows
- OZONOSAN Plastic Bag L
- OZONOSAN Plastic Bag S
- OZONOSAN Reservoir Bag 1.5 L
- OZONOSAN Wasserozonisierungseinheit
Catalogue references include 1029, 1030, 2001, 2002, 2026, 2027.
European nomenclature codes declared: G020199, V901603, Z12040280.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| 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 | 8 |
|---|---|
| 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. Hänsler Medical GmbH was not found in either the U.S. or the Canadian register.