HomeFranceBIOMET FRANCE SARL

BIOMET FRANCE SARL

France · Valence
✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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
36listed device types
Class I 14Class II 19Class III 3
plus 59 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
9registered devices
Class I 3Class II 6
16 including historic records
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
26 including historic records
TWTaiwanTFDA
3valid device licences
Class I 2Class II 1
SGSingaporeHSA SMDR
10device registrations
CLASS B 1CLASS C 4CLASS D 2D WITH MEDICINAL PRODUCT 3
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
28active ARTG entries
Class I 13Class III 5IIa 7IIb 3
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
13registrations
RURussiaRoszdravnadzor
5active registrations
Class 1 1Class 2a 1Class 2b 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 States59 registration records, 1 510(k), 0 PMA, 56 excluded
Brazil9 confirmed, 27 excluded
Saudi Arabia1 confirmed, 6 excluded
Canada0 confirmed, 14 excluded
Manufacturer names merged into this page: BIOMET FRANCE · Biomet France · BIOMET FRANCE SARL

Company information

Country
France
City
Valence

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

12026 · K254107

FDA listed device types

showing 8 of 36
Instrument, Bending Or Contouring 1Screwdriver 1Template 1Forceps, Wire Holding 1Reamer 1Pliers, Surgical 1Starter, Bone Screw 1Bit, Drill 1

Registration details (sample)

MarketIdentifierNameClass / date
USK254107Refobacin Bone Cement R (110034355)2026-04-15
BR80044680124Tubos Descartáveis OptilavageClass II
BR80044680369Tubos Optivac® para Mistura e Aplicação de Cimentos com Pressurizador Class II
BR80044680138SISTEMA OPTILAVAGEClass II
SAME0000001905SFDAA00039GTS® TRUNNION CONNECTION LID

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