EU → North America Device Access

Biomedical S.r.l.

IT-MF-000027821 · Italy · Firenze

Biomedical S.r.l. is registered in the European database on medical devices as a manufacturer, with 192 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa187
Class IIb4
Class I1

Most frequent device types declared: 0BI1410/075, Ago monouso per agoaspirazione, Ago per biopsia aspirata citologica ed istologica. Modello 0BC (sistem, Disposable needle for bone biopsy, Disposable needle for bone marrow biopsy.

Among these devices, 188 are declared sterile, 2 active.

Devices declared under this manufacturer

Showing 12 of 192 declared devices.

Catalogue references include 0BC1810, 0BD2020, 0BDS2015, 0BIE1510/075, 0BL0815, 0BLE1115.

European nomenclature codes declared: A0102010101, A01020102, Z120608, A01020201, A01020299, A01020201,A01020202.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED192
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 GTIN192
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. Biomedical S.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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