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: Spine Set, Z-Staple, Probe Navigator, Z-Guide Wire, Screwdriver.
Among these devices, 17 are declared sterile, 13 implantable, 33 reusable, 4 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |