Z-Medical GmbH + Co. KG
DE-MF-000005471 · Germany · Tuttlingen
Z-Medical GmbH + Co. KG is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 37 |
|---|---|
| Class IIb | 13 |
Most frequent device types declared: Counter Support, Handle, Handle Probe Navigator, Probe Navigator, Rodbender.
Among these devices, 17 are declared sterile, 13 implantable, 33 reusable, 4 active.
Devices declared under this manufacturer
- Adapter short
- Awl Set
- Awl flat
- Chuck Rod
- Clamping Tube
- Handle Probe Navigator
- Probe Navigator straight
- Rack
- Revision Instrument Inner Part
- Rodbender
- Rodinserter
- Turning Handle ¼“
Showing 12 of 50 declared devices.
Catalogue references include A06 081 S, A16 381, A16 385, A16 508, A16 512, A16 517.
European nomenclature codes declared: L091001, P09120101, L1199, V9012, L26, L091002.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Z-MEDICAL GMBH & CO. KG (DE) · FDA 3009110133 |
| Devices in EUDAMED | 50 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 50 |
|---|---|
| Found in the U.S. device database | 21 |
| Share | 42.0 % |
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: United States only. Z-Medical GmbH + Co. KG is registered in the United States but was not found in the Canadian register.