EU → North America Device Access

GROUP EXTREMITIES S.r.l.

IT-MF-000040729 · Italy · MILANO

GROUP EXTREMITIES S.r.l. is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa43

Among these devices, 43 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 43 declared devices.

Catalogue references include GX05S44113S, GX07S62514S, GX09S53113S, GX09S63113S, GX10S44113S, GX10S54113S.

European nomenclature codes declared: K01020199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED43
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN43
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. GROUP EXTREMITIES S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
071-00-00-MDRissued2030-04-02

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