Home›China›ZHEJIANG SHINYE MEDICAL TECHNOLOGY CORP., LTD

ZHEJIANG SHINYE MEDICAL TECHNOLOGY CORP., LTD

China · Hangzhou Zhejiang

✓ 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 10Class II 0Class III 0

plus 10 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States10 registration records, 0 510(k), 0 PMA

Brazil3 confirmed, 1 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: Zhejiang Shinye Medical Technology Corp.,Ltd · ZHEJIANG SHINYE MEDICAL TECHNOLOGY CORP., LTD

FDA listed device types

showing 8 of 10

Spring, Orthodontic 1Band, Preformed, Orthodontic 1Clamp, Wire, Orthodontic 1Tube, Orthodontic 1Instrument, Ligature Tucking, Orthodontic 1Plier, Orthodontic 1Driver, Band, Orthodontic 1Bracket, Metal, Orthodontic 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80328810061	Acessórios Ortodônticos Orthometric	Class I
BR	80328810062	Componente para Orthodontia-Orthometric	Class II
BR	80328810064	Componentes Ortodônticos - Orthometric	Class II
SA	ME0000000921SFDAA00010	Extraoral Orthodontic Appliances Accessories	—
SA	ME0000000689SFDAA00002	Orthodontic Brackets	—

ZHEJIANG SHINYE MEDICAL TECHNOLOGY CORP., LTD

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies