EU → North America Device Access

Laboratori Baldacci S.p.A.

IT-MF-000020509 · Italy · Pisa

Laboratori Baldacci S.p.A. is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Among these devices, 7 are declared sterile.

Devices declared under this manufacturer

Catalogue references include 00681, 09804, 172A, 172B, 202A, 202B.

European nomenclature codes declared: Q030199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. Laboratori Baldacci S.p.A. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
IT339129issued2030-01-12

Other manufacturers in Italy

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