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JIANGSU JIANYU HEALTH MEDICAL CO.,LTD

China · Changzhou Jiangsu · www.jianyumedical.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000019315

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Israel — 8 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

43UDI-DI device records

Class I 21Class IIa 22

USUnited StatesFDA openFDA

35listed device types

Class I 24Class II 11Class III 0

plus 35 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

12registered device records

Class I 11Class IIa 1

BRBrazilANVISA

1registered devices

Class I 1

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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1Class Is (sterile) 2

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 Union232 raw hits, 189 excluded, 43 confirmed

United States35 registration records, 1 510(k), 0 PMA, 1 excluded

United Kingdom12 confirmed, 1 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: Jiangsu JianYu Health Medical Co., Ltd · JIANGSU JIANYU HEALTH MEDICAL CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000019315
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: MedPath Limited
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

12020 · K201754

FDA listed device types

showing 8 of 35

Device, Occlusion, Umbilical 1Dental Hygiene Kit 1Container, Specimen, Sterile 1Clamp, Surgical, General & Plastic Surgery 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1Amniotome 1Restraint, Protective 1Sheet, Burn 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06979973732048	—	Class I
EU	06979973732031	—	Class I
EU	06979973732024	—	Class I
EU	06979973732017	—	Class I
UK	66033	Cleaning connecting Tube	Class I
UK	60758	Water Jet Connector	Class IIa
UK	60759	Filter for Medical Use	Class I
US	K201754	JianYu Surgical Mask	2020-12-30
BR	10188530086	CATETER URETRAL INTERMITENTE COM BOLSA COLETORA - UROSAM CATH ALVEUS	Class I

JIANGSU JIANYU HEALTH MEDICAL CO.,LTD

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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