EU → North America Device Access

Permedica S.p.A

IT-MF-000008110 · Italy · Merate

Permedica S.p.A is registered in the European database on medical devices as a manufacturer, with 1 181 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 181

Devices declared under this manufacturer

Showing 12 of 1 181 declared devices.

Catalogue references include S26344, S32758, S39742, S50282, S52766, S53560.

European nomenclature codes declared: V06010102, V06010101, S010401, Q010207, Q010280.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 181
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 GTIN1 181
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. Permedica S.p.A was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
002-00-00-MDRissued2027-07-04

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