EU → North America Device Access

Eurospital Spa

IT-MF-000028468 · Italy · Trieste

Eurospital Spa is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa1

Most frequent device types declared: Eu-Gen FII/FV Type, Eu-Gen MTHFR Dual-Type, Eu-Mag DNA/RNA extraction, Soluzione Fisiologica Eurospital DM.

Among these devices, 1 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

Catalogue references include 2043C, 9069S, 9127, 9191EP, 9241, 9242.

European nomenclature codes declared: W0106010499, W0102019009, W0201020102, W0106010115, W0102100601, W0102069009.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryEUROSPITAL S.P.A. (IT) · FDA 9615139
Devices in EUDAMED22
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN22
Found in the U.S. device database1
Share4.5 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryEUROSPITAL S.P.A.

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record15
Currently active0
Class 2 devices15
First licensed2009-06-10

Licence types: Test Kit (15).

Licensed under: EU-TTG IGA (ANTI-TISSUE TRANSGLUTAMINASE), EU-TTG IGG ENZYME IMMUNOASSAY, ALPHA-GLIAPEP IGG, ALPHA-GLIAPEP IGA, EASYCAL DEVICE FOR STOOL COLLECTION, CALPREST NG.

Notified body certificates

CertificateStatusExpiry
V13 066267 0039 Rev. 00issued2027-04-03
V13 066267 0039issued2027-04-03

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