EU → North America Device Access

Biolife Italiana s.r.l.

IT-MF-000018174 · Italy · Milan

Biolife Italiana s.r.l. is registered in the European database on medical devices as a manufacturer, with 264 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: ADDITIVES FOR CULTURE MEDIA, COLLECTION - TREATMENT SYSTEMS, IVD FOR MICROBIAL IDENTIFICATION, MEDIATUBE, PARASITOLOGY KIT.

Devices declared under this manufacturer

Showing 12 of 264 declared devices.

Catalogue references include 4016362, 4020254, 4021554, 5115412, 5120052, 5121552.

European nomenclature codes declared: W0104010101, W0104010405, W0104010206, W0104010104, W0104010306, W0104010402.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED264
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 GTIN264
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. Biolife Italiana s.r.l. was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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