HomeUSAGenesis Bps, LLC

Genesis Bps, LLC

USA · Mahwah
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 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
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 2Class 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
2active device licences
Class II 2
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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, 1 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: GENESIS BPS LLC · GENESIS BPS

Company information

Country
USA
City
Mahwah

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

12009 · K082027

Registration details (sample)

MarketIdentifierNameClass / date
USK082027FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 601602009-02-13
BR80832339008TCD TOTAL CONTAINMENT DEVICE - B40Class I
BR80125859009EXTRATOR DE PLASMA SEMI AUTOMÁTICOClass II
BR80125859008GENESIS RAPIDWELD™ STERILE TUBE WELDER (STW)Class I
CA94407PEDI-PAK PEDIATRIC TRANSFER PACKClass II
CA94409PEDI-PAK PEDI-SYRINGE FILTERClass II

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