EU → North America Device Access

Diametros Medical S.r.l. Unipersonale

IT-MF-000013449 · Italy · Firenze

Diametros Medical S.r.l. Unipersonale is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I10
Class IIb10

Most frequent device types declared: Lobster Project 2.0.

Among these devices, 20 are declared sterile, 20 implantable.

Devices declared under this manufacturer

Showing 12 of 20 declared devices.

Catalogue references include LBS08, LBS10, LBS12, LBS14, LBS16, LBT08.

European nomenclature codes declared: P09070305.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED20
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 GTIN20
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. Diametros Medical S.r.l. Unipersonale was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
ITI 2290724 1issued2029-12-08
ITH 2290724 1issued2029-12-08

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