EU → North America Device Access

Phönix-PACS GmbH

DE-MF-000005785 · Germany · Freiburg

Phönix-PACS GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Among these devices, 5 are declared active.

Catalogue references include 5.8.1, 7.0, 7.1, 7.3, 7.4.

European nomenclature codes declared: Z11069092.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationGermany

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

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. Phönix-PACS GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
Z-24-077-S-IX-Eissued2031-01-20
Z-24-077-S-IXissued2031-01-20

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