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SHIJIAZHUANG YUANDING MEDICAL DEVICE CO.,LTD

China · Shijiazhuang Hebei · www.yuandingmed.cn

✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000010432

This company has registrations in European Union, United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 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

121UDI-DI device records

Class I 93IVD A 28

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

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.

European Union121 raw hits, 0 excluded, 121 confirmed

United States2 registration records, 0 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: SHIJIAZHUANG YUANDING MEDICAL DEVICE CO.,LTD · SHIJIAZHUANG YUANDING MEDICAL DEVICE CO., LTD · Shijiazhuang Yuanding Medical Device Co., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000010432
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06979166920160	Canister	Class I
EU	06979166920146	Canister	Class I
EU	06979166920153	Canister	Class I
EU	06979166920139	Canister	Class I
BR	80400320013	DRENO DE SUCÇÃO PARA HIGIENIZAÇÃO ORAL - ORAL CARE	Class I
BR	80400320010	YD SUCTION LINER	Class II
SA	ME0000001574SFDAA00004	Suction Liner	—

SHIJIAZHUANG YUANDING MEDICAL DEVICE CO.,LTD

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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