HomeUSABIOMET BIOLOGICS, INC.

BIOMET BIOLOGICS, INC.

USA · Warsaw
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in Brazil, Canada, Singapore, Hong Kong, Israel — 5 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
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
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
40active device licences
Class II 5Class III 35
277 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
3valid listings
Class II 1Class III 1Class IV 1
ILIsraelAMAR
3registrations
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.

United States0 registration records, 0 510(k), 0 PMA, 35 excluded
Brazil2 confirmed, 2 excluded
Canada40 confirmed, 5 excluded
Manufacturer names merged into this page: BIOMET ORTHOPEDICS, ATA BIOMET SPORTS MEDICINE, ATA BIOMET BIOLOGICS, ATA BIOMET TRAUMA · BIOMET BIOLOGICS, INC. · BIOMET BIOLOGICS

Company information

Country
USA
City
Warsaw

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.

Registration details (sample)

MarketIdentifierNameClass / date
BR80044680454Sistema de descompressão PerfuseClass II
BR80044680081Centrífuga Biomet BiologicsClass I
CA1012ASCENT KNEE PROSTHESISClass III
CA3083REPICCI II UNICONDYLAR KNEEClass III
CA11838AGC MOLDED TIBIAL COMPONENTClass III

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