HomeChinaSHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.

SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD.

China · Shenzhen Guangdong
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
10listed device types
Class I 9Class II 0Class III 0unclassified 1
plus 9 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class I 5Class II 6
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
5registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
10active ARTG entries
Class I 3IIa 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
4active registrations
Class 1 2Class 2a 2
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, 1 510(k), 0 PMA, 24 excluded
Brazil11 confirmed, 5 excluded
Saudi Arabia5 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD. · SHENZHEN PERFECT MEDICAL INSTRUMENTS CO · SHENZHEN PERFECT MEDICAL INSTRUMENTS CO. LTD. · SHENZHEN PERFECT MEDICAL INSTRUMENTS CO., LTD · SHENZHEN PERFECT MEDICAL INSTRUMENTS CO LTD · Shenzen Perfect Medical Instruments Co., Ltd.

Company information

Country
China
City
Shenzhen Guangdong

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

12023 · K222548

FDA listed device types

showing 8 of 10
Bur, Dental 1Handpiece, Direct Drive, Ac-Powered 1Point, Paper, Endodontic 1Needle, Dental 1File, Pulp Canal, Endodontic 1Gutta-Percha 1Pick, Massaging 1Handle, Instrument, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK222548Endo Motor2023-04-26
BR10347940143EXTIRPA NERVOS PERFECTMASTERClass II
BR80803280001D Perfect Stainless SteelClass I
BR10347940141LIMAS PERFECTMASTERClass II
SAME0000005590SFDAA00001Layan ® Perfect Endodontic File
SAME0000009476SFDAA00005Carbide Burs

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