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Home›KLARITY MEDICAL & EQUIPMENT CO., LTD.

KLARITY MEDICAL & EQUIPMENT CO., LTD.

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Israel, Russia — 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
3listed device types
Class I 2Class II 1Class III 0
plus 8 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
14registered devices
Class I 14
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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, 3 510(k), 0 PMA, 2 excluded
Brazil14 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD. · KLARITY MEDICAL & EQUIPMENT CO., LTD. · Guangzhou Klarity Medical & Equipment Co., Ltd · KLARITY MEDICAL AND EQUIPMENT (GZ) CO., LTD
Same-named companies — This database also contains companies with near-identical names: KLARITY MEDICAL AND EQUIPMENT (GZ) 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

12021 · K202747
12022 · K220539
12025 · K241937

FDA listed device types

Accelerator, Linear, Medical 1Holder, Head, Radiographic 1Splint, Hand, And Components 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241937Klarity SGRT System (ARSG-E1A, ARSG-E3A)2025-03-18
USK220539Klarity SRS Baseplate, Klarity Promise Baseplate2022-11-01
USK202747Klarity Bolus2021-05-14
BR80186820026MÁSCARA TERMOPLÁSTICA KLARITY®Class I
BR80186820027ACESSÓRIOS PARA IMOBILIZAÇÃO KLARITY ®Class I
BR80186820013POSICIONADORES EM FIBRA DE CARBONOClass I
SAME0000010977SFDAA00001KLARITY—

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