HomeItalyGeneral Medical Merate S.p.A.

General Medical Merate S.p.A.

Italy · Seriate (BG) · www.gmmspa.com
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Israel, Russia — 9 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
5listed device types
Class I 0Class II 5Class III 0
plus 3 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
7registered device records
Class I 4Class IIb 3
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
9active registrations
Class 2a 3Class 2b 6
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.

United States3 registration records, 7 510(k), 0 PMA
United Kingdom7 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: GENERAL MEDICAL MERATE S.P.A. · GENERAL MEDICAL MERATE SPA · General Medical Merate SpA

Regulatory identity

UK responsible person
QCS International LTD.

Company information

Country
Italy
City
Seriate (BG)
Website
www.gmmspa.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsX-ray (analog, digital, mobile)

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
815600C6D3995C954256
Registration status
Active
Legal form
Società Per Azioni (SPA)
Incorporated
1971-12-02
Registered address
VIA PARTIGIANI, 25, SERIATE, 24068
Registration authority
Business Register, no. 00225500164
Registry record updated
2026-03-31

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

11982
11988
12004
12008
12014
12018
12021

FDA listed device types

Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Table, Radiologic 1System, X-Ray, Tomographic 1System, X-Ray, Angiographic 1System, X-Ray, Fluoroscopic, Image-Intensified 1

Registration details (sample)

MarketIdentifierNameClass / date
UK40655POSIZIONATOREClass I
UK37646GMMClass IIb
UK15726STRETCHERClass I
USK213081CLISIS SYSTEMS, Discovery RF1802021-10-26
USK173395MECALL CLISIS SYSTEMS, Discovery RF1802018-05-21
USK140380OPERA SWING2014-09-26
SAME0000002249SFDAA00006MSP 150

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