HomeIsraelB.J.M. LABORATORIES LTD

B.J.M. LABORATORIES LTD

Israel · Or-Yehuda Central
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, South Korea, Israel — 4 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
9listed device types
Class I 1Class II 7Class III 0unclassified 1
plus 21 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
3valid device licences
Class I 1Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
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 States21 registration records, 1 510(k), 0 PMA, 612 excluded
Brazil0 confirmed, 56 excluded
Saudi Arabia0 confirmed, 10 excluded
Canada0 confirmed, 71 excluded
Manufacturer names merged into this page: B.J.M. LABORATORIES LTD

Company information

Country
Israel
City
Or-Yehuda Central

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

11984 · K840975

FDA listed device types

showing 8 of 9
Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Adhesive, Bracket And Tooth Conditioner, Resin 1Material, Tooth Shade, Resin 1Varnish, Cavity 1Resin, Root Canal Filling 1Agent, Tooth Bonding, Resin 1Agent, Polishing, Abrasive, Oral Cavity 1

Registration details (sample)

MarketIdentifierNameClass / date
USK840975RICO RESPIRATION MONITOR1984-03-30

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