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BD MEDICAL - PHARMACEUTICAL SYSTEMS

USA · Franklin Lakes
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia — 6 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
4listed device types
Class I 1Class II 3Class III 0
plus 8 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class 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
5active device licences
Class II 5
9 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class Im (measuring) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States8 registration records, 1 510(k), 0 PMA, 36 excluded
Brazil1 confirmed, 5 excluded
Canada5 confirmed, 3 excluded
Manufacturer names merged into this page: BD MEDICAL · BD MEDICAL - PHARMACEUTICAL SYSTEMS
Same-named companies — This database also contains companies with near-identical names: Bd Medical Systems. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Franklin Lakes

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

12001 · K010188

FDA listed device types

Syringe, Antistick 1Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact 1Syringe, Piston 1Brush, Scrub, Operating-Room 1

Registration details (sample)

MarketIdentifierNameClass / date
USK010188BD ECLIPSE HYPODERMIC NEEDLE2001-03-01
BR10033430526CANETA APLICADORAClass II
CA2721B-D AUTO-INJECTORClass II
CA14722HYPOINT NEEDLESClass II
CA63971BD SAFETY-LOK INFUSION SET WITH FILTERClass II

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