EU → North America Device Access

AFERETICA S.R.L.

IT-MF-000029731 · Italy · Bologna

AFERETICA S.R.L. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Among these devices, 5 are declared sterile, 3 active.

Devices declared under this manufacturer

Catalogue references include AF05702, AF05705, AF093100, AF093200, AF94000, AF94051.

European nomenclature codes declared: C0399, A090199, Z12019002, A0980.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. AFERETICA S.R.L. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITH 1343916 1supplemented2029-10-17
ITH 1343916 1reissued2029-10-17

Other manufacturers in Italy

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