EU → US Device Access

Cardio Medical GmbH

DE-MF-000025445 · Germany · Langenhagen

Cardio Medical GmbH is registered in the European database on medical devices as a manufacturer, with 126 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa126

Most frequent device types declared: CV 393.75, CV 193.95, CV 193.50, CV 198.30, CV 398.30.

Among these devices, 126 are declared reusable.

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 entryCARDIO MEDICAL PRODUCTS, INC. (US) · FDA 2246340
Devices in EUDAMED126
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
D1443900007issued2030-04-15

Other manufacturers in Germany

All Germany manufacturers →