HomeAustraliaMicro-X Limited

Micro-X Limited

Australia · Tonsley South
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, South Korea, Australia, Israel — 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
6listed device types
Class I 4Class II 2Class III 0
plus 10 registration records and 9 510(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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States10 registration records, 9 510(k), 0 PMA, 116 excluded
Brazil0 confirmed, 28 excluded
Saudi Arabia0 confirmed, 4 excluded
Canada0 confirmed, 10 excluded
Manufacturer names merged into this page: MICRO-NX CO., LTD. · MICRO-X LTD

Company information

Country
Australia
City
Tonsley South

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

ABN
21153273735
Registration status
Active
Legal form
Australian Public Company
Registered address
SA, 5042

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

12017
22020 · K192809
22021 · K201192
22022 · K220577
12023 · K232810
12025 · K231562

FDA listed device types

Handpiece, Direct Drive, Ac-Powered 1Handpiece, Belt And/Or Gear Driven, Dental 1Controller, Foot, Handpiece And Cord 1Handpiece, Contra- And Right-Angle Attachment, Dental 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231562ELEC ENGINE (Model: ISE-170L)2025-07-18
USK232810Dental Handpiece, Wireless Endodontic Handpiece, endoit2023-11-09
USK220577Dental Handpiece, Model CA160, CA160L, and CA500L2022-07-29

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