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Hubei Yazhi Hygiene Products Co., Ltd

China · Xiantao Hubei · www.hubeiyazhi.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000010782

This company has registrations in European Union, United States, Brazil, Israel — 4 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

148UDI-DI device records

Class I 148

USUnited StatesFDA openFDA

6listed device types

Class I 5Class II 0Class III 0unclassified 1

plus 6 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 Union148 raw hits, 0 excluded, 148 confirmed

United States6 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: HUBEI YAZHI HYGIENE PRODUCTS CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000010782
EU authorised representative: SUNGO Europe B.V.

FDA listed device types

Cap, Surgical 1Accessory, Surgical Apparel 1Non-Surgical Gown 1Cover, Shoe, Operating-Room 1Bedding, Disposable, Medical 1Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08435454011739	—	Class I
EU	08435454011845	—	Class I
EU	08435454011234	—	Class I
EU	08435454011227	—	Class I
BR	83302990002	MASCARA FACIAL DESCARTÁVEL	Class I
BR	81840540009	AVENTAL DESCARTÁVEL D'PACK	Class I
BR	81840540012	AVENTAL DE PROCEDIMENTO D'PACK	Class I

Hubei Yazhi Hygiene Products 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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