EU → US Device Access

RAPID Biomedical GmbH

DE-MF-000008285 · Germany · Rimpar

RAPID Biomedical GmbH is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa78

Among these devices, 72 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 registerRegistered with FDA
Matched entryRAPID BIOMEDICAL GMBH (DE) · FDA 3005049692
Devices in EUDAMED78
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
HZ 1419035-1issued2026-02-11
HZ 1419035-1reissued2031-02-11

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