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Apoza Enterprise Col, Ltd

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 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
7listed device types
Class I 5Class II 2Class III 0
plus 9 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States9 registration records, 5 510(k), 0 PMA
Saudi Arabia2 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: APOZA ENTERPRISE CO., LTD. · APOZA ENTERPRISE CO LTD · Apoza Enterprise Col, Ltd
Same-named companies — This database also contains companies with near-identical names: APOZA ENTERPRISE CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

12003 · K033201
32004 · K041303
12007 · K070373

FDA listed device types

Light, Fiber Optic, Dental 1Plugger, Root Canal, Endodontic 1Unit, Operative Dental, Accessories 1Heat Source For Bleaching Teeth 1Disinfectant, Medical Devices 1Scaler, Ultrasonic 1Activator, Ultraviolet, For Polymerization 1

Registration details (sample)

MarketIdentifierNameClass / date
USK070373APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W2007-03-02
USK041303LED TURBO-PEN2004-06-18
USK033198APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U22004-04-30
SAME0000003009SFDAA00001APOZA ®—
SAME0000009472SFDAA00001BT COOL—
CA81898AUTOCLAVE AD7Class II
CA88801ULTRASONIC SCALERSClass II

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