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CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.

China · Changzhou

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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

14listed device types

Class I 8Class II 5Class III 0unclassified 1

plus 14 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 7Class II 10

19 including historic records

SASaudi ArabiaSFDA

8registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

18 including historic records

TWTaiwanTFDA

12valid device licences

Class I 11Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

23active ARTG entries

Class I 8IIa 14IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

8active registrations

Class 2a 8

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 States14 registration records, 4 510(k), 0 PMA

Brazil17 confirmed, 0 excluded

Saudi Arabia8 confirmed, 0 excluded

Manufacturer names merged into this page: CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD · Changzhou Sifary Medical Technology Co.,Ltd.

FDA 510(k) clearances by year

12021 · K201993

12022 · K221152

12023 · K232068

12026 · K252224

FDA listed device types

showing 8 of 14

Handpiece, Direct Drive, Ac-Powered 1Plugger, Root Canal, Endodontic 1Loupe, Diagnostic/Surgical 1Microscope, Surgical 1File, Pulp Canal, Endodontic 1Pick, Massaging 1Accessories, Implant, Dental, Endosseous 1Light, Surgical Headlight 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252224	Apex Locator (FindPex)	2026-04-08
US	K232068	HyperLight Portable X-ray Unit	2023-09-01
US	K221152	CuringPen Dental Curing Light	2022-11-23
BR	82195309035	Dental Implant Unit	Class II
BR	10320740038	Scan Body Kit	Class I
BR	82195300040	Scan Body Kit	Class I
SA	ME0000010172SFDAA00003	Extraoral Dental Vacuum System	—
SA	ME0000010172SFDAA00008	Dental Curing Light	—

CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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