EU → North America Device Access

BIOTECK S.p.A.

IT-MF-000011484 · Italy · Arcugnano (VI)

BIOTECK S.p.A. is registered in the European database on medical devices as a manufacturer, with 250 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I250

Among these devices, 250 are declared sterile, 249 implantable, 1 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 250 declared devices.

Catalogue references include ACT-PTY030, BCG-05, BCG-200, BGM-05s, BGM-10s, OGS-ACM40.

European nomenclature codes declared: P900401,P900402.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED250
Country of registrationItaly

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

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. BIOTECK S.p.A. was not found in either the U.S. or the Canadian register.

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