Zfx GmbH
DE-MF-000018101 · Germany · Dachau
Zfx GmbH is registered in the European database on medical devices as a manufacturer, with 159 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 64 |
|---|---|
| Class IIb | 95 |
Among these devices, 95 are declared implantable, 39 reusable.
Devices declared under this manufacturer
- GenTek ®
- GenTek®
Showing 12 of 159 declared devices.
Catalogue references include ZFX02HLD36, ZFX05Z-ZB-EX-41, ZFX05Z-ZB-TSV-45, ZFX09-ST-SC, ZFX09000627, ZFX11ZB-CE34AS26E.
European nomenclature codes declared: Q01010199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Zfx GmbH (DE) · FDA 3008932779 |
| Devices in EUDAMED | 159 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 159 |
|---|---|
| Found in the U.S. device database | 76 |
| Share | 47.8 % |
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: United States only. Zfx GmbH is registered in the United States but was not found in the Canadian register.