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Z-Medical GmbH + Co. KG

Active in EUDAMED

Germanyfrom SRN EUDAMED FDA SRN DE-MF-000005471

Devices
305
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment

What Z-Medical GmbH + Co. KG makes

Z-Medical GmbH + Co. KG manufactures orthopedic surgical instruments and fixation devices, including distraction and compression tools, reamers, drills, and staples. Their portfolio also covers curved awls, threaded drills, and clamping tubes, as well as mounting racks and quarter-inch turning handles for surgical procedures. The company produces both single-use and reusable components for spinal and joint stabilization applications.

The company’s devices are classified under EU Medical Device Regulations as Class I and Class IIb, with all relevant products listed in the EU’s eudamed database. Their instruments comply with European regulatory requirements, ensuring traceability and market conformity. The manufacturer is based in Germany.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
DE-MF-000005471
DUNS number
332068761
EU VAT number
DE813 564 906
EUDAMED status
Active
EUDAMED registered name
Z-Medical GmbH + Co. KG
Registered address
38, Gänsäcker, 78532, Tuttlingen, Germany
Website
z-medical.de
Phone
+497462945540
PRRC contact
Kirill Kipke(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Z-Medical GmbH & Co. KG US

Frequently asked questions

How many devices does Z-Medical GmbH + Co. KG have in the registry?

The registry currently lists 305 devices for Z-Medical GmbH + Co. KG. Devices recorded under merged duplicate company entries are counted once.

Which registries list Z-Medical GmbH + Co. KG's devices?

Among its 50 most recently registered devices, Z-Medical GmbH + Co. KG has devices listed in EUDAMED (1 device) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Z-Medical GmbH + Co. KG's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Z-Medical GmbH + Co. KG's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Z-Medical GmbH + Co. KG in the registry?

The most recently registered devices listed for Z-Medical GmbH + Co. KG include NA A06075_US, Z-Pedicle Screw A06 461, Z-Pedicle Screw A06 191 and NA A06061_US.

Which FDA establishments are linked to Z-Medical GmbH + Co. KG?

1 FDA establishment is linked to Z-Medical GmbH + Co. KG in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.