EU → North America Device Access

CODAN pvb Critical Care GmbH

DE-MF-000007510 · Germany · Forstinning

CODAN pvb Critical Care GmbH is registered in the European database on medical devices as a manufacturer, with 951 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb574
Class IIa377

Most frequent device types declared: Xtrans® / DPT-6000 , ABSS, Xtrans® / DPT-6000 , CLC, Xtrans® / DPT-6000 , NBSS, Xtrans® / DPT-6000 , SWAN Switch, Xtrans®/DPT-6000 , CLC.

Among these devices, 707 are declared sterile, 574 active.

Devices declared under this manufacturer

Showing 12 of 951 declared devices.

Catalogue references include 74.4176, 74.4838, 74.6076, 74.6337, 74.7021, 74.7172.

European nomenclature codes declared: Z1203020301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED951
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 GTIN951
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. CODAN pvb Critical Care GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
G10 060815 0012issued2029-01-21

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