EU → North America Device Access

PENTAFERTE ITALIA SRL

IT-MF-000040982 · Italy · Campli

PENTAFERTE ITALIA SRL is registered in the European database on medical devices as a manufacturer, with 232 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa228
Class IIb4

Among these devices, 230 are declared sterile, 65 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 232 declared devices.

Catalogue references include 002022C30, 004021E14, 004021M05, 032022AC06WD2, 032022AC09WD, 032022AC27WD.

European nomenclature codes declared: A020108, G02020101, A0101010102, A020102010201, A020102020102, A020102020101.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryPENTAFERTE ITALIA S.R.L. (IT) · FDA 3004756837
Devices in EUDAMED232
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN232
Found in the U.S. device database11
Share4.7 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

Other manufacturers in Italy

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