HomeFranceFIM MEDICAL SAS

FIM MEDICAL SAS

France · Villeurbanne · fim-medical.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN FR-MF-000017090

This company has registrations in European Union, United States, United Kingdom, Australia — 4 overseas markets. EU UDI-DI records ≥1, the first 300 verified individually. 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
≥1UDI-DI device records
Class IIa 1
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
4listed device types
Class I 1Class II 3Class III 0
plus 4 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 2Class IIa 3
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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 Union521 raw hits, 299 excluded, 1 confirmed. Large result set — only the first 300 verified
United States4 registration records, 4 510(k), 0 PMA
United Kingdom5 confirmed, 2 excluded
Manufacturer names merged into this page: FIM MEDICAL

Regulatory identity

EU manufacturer SRN
FR-MF-000017090
UK responsible person
Oticon Limited

Company information

Country
France
City
Villeurbanne
Website
fim-medical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentENT & audiology

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
FIM MEDICAL
SIREN
391853090
Registration status
Active
Legal form
Société par actions simplifiée (SAS)
Incorporated
1993-07-01
Principal activity
Fabrication de matériel médico-chirurgical et dentaire (32.50A)
Employee size band
20–49
Registered address
51 RUE ANTOINE PRIMAT 69100 VILLEURBANNE

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

FDA 510(k) clearances by year

12002 · K010761
12005 · K050424
12008 · K080278
12016 · K161676

FDA listed device types

Chart, Visual Acuity 1Spirometer, Diagnostic 1Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase 1Audiometer 1

Registration details (sample)

MarketIdentifierNameClass / date
EU03760253450003Spirolyser Q13Class IIa
UK35467TABATABA V3Class I
UK13680Spirolyser® Q13®Class IIa
UK61097SP1 ®Class IIa
USK161676Q13 SPIROLYSER®2016-10-20
USK080278TABATABA COTESTER2008-11-28
USK050424ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-502005-06-23

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