EU → North America Device Access

CINOGY GmbH

DE-MF-000048574 · Germany · Duderstadt

CINOGY GmbH is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7
Class IIb7

Among these devices, 7 are declared sterile, 7 active.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include 22180, 22200, K25200, K25204, K25300, K25301.

European nomenclature codes declared: Z12019003.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
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 GTIN14
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. CINOGY GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
CR-03-1211-881-25issued2030-08-14

Other manufacturers in Germany

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