EU → North America Device Access

HPF S.R.L.

IT-MF-000017541 · Italy · Flagogna di Forgaria nel Friuli (UD)

HPF S.R.L. is registered in the European database on medical devices as a manufacturer, with 1 108 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa1 108

Most frequent device types declared: ACETABULAR REAMER EVO, Accessory handle, Chisel osteotome blade with slot, Curved thin osteotome blade with hole, Drill bits.

Among these devices, 1 058 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 1 108 declared devices.

Catalogue references include 200-2055, 9055.28.442, H0030604699, H0034000299, H0035556499, H0050152009.

European nomenclature codes declared: L091102, L090404, V06010101, L091199, P091301, L0916.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHPF S.R.L. (IT) · FDA 3009546990
Devices in EUDAMED1 108
Country of registrationItaly

Device-level evidence

Devices with a numeric GTIN1 108
Found in the U.S. device database931
Share84.0 %

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: United States only. HPF S.R.L. is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
G10 082526 0002issued2028-10-26

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