HomeFranceBIOMERIEUX S A

BIOMERIEUX S A

France · Marcy-L'Etoile
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Hong Kong, 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
pendingnot queried
USUnited StatesFDA openFDA
16510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
12registered devices
Class I 6Class II 6
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
30valid device licences
Class I 16Class II 14
SGSingaporeHSA SMDR
47device registrations
CLASS B 18CLASS C 25CLASS D 4
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
IVD import 3
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
49valid listings
IVD B 21IVD C 20IVD D 8
ILIsraelAMAR
22registrations
RURussiaRoszdravnadzor
5active registrations
Class 1 2Class 2a 3
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 States0 registration records, 16 510(k), 0 PMA, 18 excluded
Brazil12 confirmed, 9 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: BIOMERIEUX S A · BIOMERIEUX S.A. · BIOMÉRIEUX S.A.

Company information

Country
France
City
Marcy-L'Etoile

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.

FDA 510(k) clearances by year

12011
32013
22015
12017
22018
52019
12021
12025

Registration details (sample)

MarketIdentifierNameClass / date
USK250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)2025-04-30
USK210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)2021-11-12
USK192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)2019-11-26
BR10158120260OLEO DE PARAFINA ( HUILE DE PARAFFINE )Class I
BR10158120264McFARLAND STANDARD ( PADRÃO McFARLAND )Class I
BR10158120251SUSPENSION MEDIUM (MEIO DE SUSPENSAO)Class I

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