EU → North America Device Access

Eurosirel Spa

IT-MF-000005982 · Italy · Cusago

Eurosirel Spa is registered in the European database on medical devices as a manufacturer, with 777 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa691
Class I83
Class IIb1

Most frequent device types declared: CCS, CMS, CR, CSS, CTS.

Among these devices, 57 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 777 declared devices.

Catalogue references include BEC056696, BK079894, CME110123, CME112127, CME459027, CMU002143.

European nomenclature codes declared: M0599, M04010199, M050101, M040412, R9099, M0304010202.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryEUROSIREL S.P.A (IT) · FDA 3015892095
Devices in EUDAMED777
Country of registrationItaly

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN777
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.

Notified body certificates

CertificateStatusExpiry
CVD005826issued2030-08-06
CSQ0031250126supplemented2030-08-06
293/MDRissued2031-06-11

Other manufacturers in Italy

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