HomeItalyF.L. MEDICAL s.r.l.

F.L. MEDICAL s.r.l.

Italy · Torreglia (PD) · www.flmedical.com
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia, Israel, Russia — 6 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
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 1 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 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 Union714,378 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States0 registration records, 1 510(k), 0 PMA, 8,881 excluded
United Kingdom0 confirmed, 1,823 excluded
Brazil1 confirmed, 2,571 excluded
Saudi Arabia1 confirmed, 967 excluded
Canada0 confirmed, 1,238 excluded
Manufacturer names merged into this page: F.L. MEDICAL S.R.L · F.L.Medical s.r.l.

Company information

Country
Italy
City
Torreglia (PD)
Website
www.flmedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsHematology & coagulationIntegrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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
815600EC5B910DE53C66
Registration status
Active
Legal form
Società A Responsabilità Limitata (SRL)
Incorporated
1984-03-27
Registered address
VIA ENRICO MATTEI, 20, TORREGLIA, 35038
Registration authority
Business Register, no. 01134840287
Registry record updated
2025-10-03

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

11993 · K923464

Registration details (sample)

MarketIdentifierNameClass / date
USK923464URODYNAMIC CATHETERS1993-02-05
BR80937150078FAMÍLIA SOL-M TUBOS PARA COLETA DE SANGUE A VÁCUOClass I
SAME0000005016SFDAA00001Foam Trays

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