EU → US Device Access

WOLF-Medizintechnik GmbH

DE-MF-000005165 · Germany · St. Gangloff

WOLF-Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb10

Most frequent device types declared: T-200, T-105, T-150, T-300, T-200 .

Among these devices, 10 are declared 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 registerNot found in the FDA register
Devices in EUDAMED10
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
2025-MDR/QS-082issued2029-11-15
2024-MDR/QS-064issued2029-11-15
2023-MDR/QS-024issued2028-08-21

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