HomeIndiaBIORAD MEDISYS PVT. LTD.

BIORAD MEDISYS PVT. LTD.

India · Pune Mah?R?Shtra
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Russia — 3 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
17listed device types
Class I 7Class II 10Class III 0
plus 17 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
87registered devices
Class I 5Class II 82
94 including historic records
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
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
20active registrations
Class 1 2Class 2a 11Class 2b 7
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 States17 registration records, 1 510(k), 0 PMA
Brazil87 confirmed, 0 excluded
Manufacturer names merged into this page: BIORAD MEDISYS PVT. LTD. · BIORAD MEDISYS PRIVATE LIMITED
Same-named companies — This database also contains companies with near-identical names: BIORAD MEDISYS PRIVATE LIMITED. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
India
City
Pune Mah?R?Shtra

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

12021 · K200765

FDA listed device types

showing 8 of 17
Dislodger, Stone, Basket, Ureteral, Metal 1Enteral Administration Kit (Adult & Pediatric) 1Endoscopic Guidewire, Gastroenterology-Urology 1Dilator, Urethral 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1Trocar, Gastro-Urology 1Carrier, Sponge, Endoscopic 1Ligator, Hemorrhoidal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK200765Genius / Genuin Total Knee System2021-05-05
BR80459130015TROCATER INDOVASIVEClass II
BR80459130050Bainha de AmplatzClass II
BR80459139014Equipo para Bomba de Irrigação Descartável IndovasiveClass II

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