HomeItalyEurospital S.p.A.

Eurospital S.p.A.

Italy · Trieste · www.eurospital.com
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, United Kingdom, Canada, Israel, Russia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 8 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
26registered device records
IVD A 7IVD B 3IVD C 2IVD general 13IVD Devices for Self-Testing 1
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
5active device licences
Class II 5
21 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
2active registrations
Class 1 1Class 2a 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union22 raw hits, 22 excluded, 0 confirmed
United States8 registration records, 4 510(k), 0 PMA, 1 excluded
United Kingdom26 confirmed, 0 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: EUROSPITAL S.P.A.

Regulatory identity

UK responsible person
Qarad UK Ltd.

Company information

Country
Italy
City
Trieste
Website
www.eurospital.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

LEI
815600754A201B4B2E94
Registration status
Active
Legal form
Società Per Azioni (SPA)
Incorporated
1948-09-15
Registered address
VIA FLAVIA, 122, TRIESTE, 34147
Registration authority
Business Register, no. 00047510326
Registry record updated
2025-10-05

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12014 · K130945
12016 · K160447
22019 · K191592

FDA listed device types

Antibodies, Gliadin 1Calprotectin, Fecal 1Autoantibodies, Endomysial(Tissue Transglutaminase) 1

Registration details (sample)

MarketIdentifierNameClass / date
UK58237Calprest Turbo extraction kitIVD A
UK53624Calprest Turbo NGIVD B
UK53624Accusay Calprotectin PlusIVD general
USK191592CalprestNG, EasyCal2019-07-10
USK191589Calprest, EasyCal2019-07-10
USK160447Calprest NG2016-11-10
CA80011SECURMIX CONTAINERSClass II
CA88430HELORI ASTClass II
CA89448CALPRESTClass II

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