EU → North America Device Access

CRYO BIO SYSTEM

FR-MF-000001630 · France · SAINT-OUEN-SUR-ITON

CRYO BIO SYSTEM is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa31

Among these devices, 28 are declared sterile, 2 active.

Devices declared under this manufacturer

Showing 12 of 31 declared devices.

Catalogue references include 007454, 010287, 010288, 017799, 023722, 025250.

European nomenclature codes declared: U08020401, U080299, U080207.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCRYO BIO SYSTEM (FR) · FDA 3003244268
Devices in EUDAMED31
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN31
Found in the U.S. device database24
Share77.4 %

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: United States only. CRYO BIO SYSTEM is registered in the United States but was not found in the Canadian register.

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