HomeAustraliaBAXTER LABORATORIES

BAXTER LABORATORIES

Australia · Boronia Victoria
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 3 510(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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
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 States1 registration records, 3 510(k), 0 PMA, 40 excluded
Brazil0 confirmed, 13 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 11 excluded
Manufacturer names merged into this page: BAXTER LABORATORIES

Company information

Country
Australia
City
Boronia Victoria

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.

Business registration

Legal name
BAXTER LABORATORIES PTY. LTD.
ABN
42093625435
Registration status
Active
Legal form
Australian Private Company
Registered address
VIC, 3155

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11988 · K882892
21991 · K905311

FDA listed device types

Eraser, Dental Stain 1

Registration details (sample)

MarketIdentifierNameClass / date
USK905311DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.1991-01-15
USK905312DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS1991-01-15
USK882892MEMBRANE OXYGENATOR1988-09-27

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