HomeItalyFLAEM NUOVA SPA

FLAEM NUOVA SPA

Italy · Desenzano Del Garda (BS) · www.flaemnuova.it
✓ Record-verifiedregistrations found in 8 marketsEU SRN IT-MF-000007769

This company has registrations in European Union, United States, United Kingdom, Canada, South Korea, Australia, Israel, Russia — 8 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
9UDI-DI device records
Class IIa 9
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
13registered device records
Class I 4Class IIa 7System or Procedure Pack 2
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
1active device licences
Class II 1
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
12active ARTG entries
Class I 2IIa 9IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
9active registrations
Class 2a 9
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 Union9 raw hits, 0 excluded, 9 confirmed
United States2 registration records, 2 510(k), 0 PMA
United Kingdom13 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: FLAEM NUOVA S.P.A. · FLAEM NUOVA SPA

Regulatory identity

EU manufacturer SRN
IT-MF-000007769
UK responsible person
Qserve Group UK, Ltd.

Company information

Country
Italy
City
Desenzano Del Garda (BS)
Website
www.flaemnuova.it
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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

Legal name
FLAEM NUOVA S.P.A.
LEI
8156000B9091311D5302
Registration status
Active
Legal form
Società Per Azioni (SPA)
Incorporated
1979-10-09
Registered address
VIA COLLI STORICI, 221-223-, DESENZANO DEL GARDA, 25015
Registration authority
Business Register, no. 01150910170
Registry record updated
2025-10-01

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

22007 · K062484

FDA listed device types

Exerciser, Non-Measuring 1Pump, Nebulizer, Electrically Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08018294016241Class IIa
EU08018294015879Class IIa
EU08018294016166Class IIa
EU08018294015794Class IIa
UK66295LightnebClass IIa
UK354574NebClass IIa
UK13730Hygiene boxClass I
USK062484FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS2007-06-08
USK062014FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB2007-03-22
CA64088UNIVERSAL IIIClass II

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