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UNITED DENTAL CHANGZHOU

China · Changzhou

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 7 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

12listed device types

Class I 12Class II 0Class III 0

plus 12 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

6registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 2IIa 3Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 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 States12 registration records, 0 510(k), 0 PMA, 110 excluded

Brazil3 confirmed, 18 excluded

Saudi Arabia6 confirmed, 4 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: UNITED DENTAL CHANGZHOU · United Dental Changzhou

FDA listed device types

showing 8 of 12

Point, Paper, Endodontic 1Syringe, Periodontic, Endodontic, Irrigating 1Plugger, Root Canal, Endodontic 1Clamp, Wire, Orthodontic 1Gutta-Percha 1File, Pulp Canal, Endodontic 1Instrument, Manual, Surgical, General Use 1Unit, Oral Irrigation 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80666979005	Ponta de Irrigação Bondent UDG	Class II
BR	80666979008	Limas NiTi Bondent UDG estéreis	Class II
BR	80666979004	Limas NiTi Bondent UDG	Class II
SA	ME0000003585SFDAA00001	Stainless Steel C Files	—
SA	ME0000003582SFDAA00001	Stainless Steel K Files	—

UNITED DENTAL CHANGZHOU

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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