EU → US Device Access

pfm medical hico GmbH

DE-MF-000012921 · Germany · Köln

pfm medical hico GmbH is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa27
Class IIb6

Among these devices, 25 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 registerSimilar name found — unverified
Matched entryPFM Medical GmbH (DE) · FDA 9617465
Devices in EUDAMED33
Country of registrationGermany
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
FI24/00000026amended2029-04-17

Other manufacturers in Germany

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