EU → North America 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 was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa126

Most frequent device types declared: CV 193.50, CV 193.95, CV 198.30, CV 393.03, CV 393.13.

Among these devices, 126 are declared reusable.

Catalogue references include CV 193.50, CV 193.95, CV 198.30, CV 393.03, CV 393.13, CV 393.75.

European nomenclature codes declared: L0205, L010403, L03130402, L091307, L0207, H020303.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED126
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN126
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Cardio Medical GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
D1443900007issued2030-04-15

Other manufacturers in Germany

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