EU → US 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 , CLC, Zubehör / Accessory IBPM, Xtrans® / DPT-6000 , NBSS, Xtrans® / DPT-6000 , ABSS, Zubehör / Accessory IBPM.

Among these devices, 707 are declared sterile, 574 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 registerNot found in the FDA register
Devices in EUDAMED951
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
G10 060815 0012issued2029-01-21

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