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Hangzhou Jinlin Medical Appliances Co., Ltd.

✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000012391

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

23UDI-DI device records

Class I 12Class IIa 11

USUnited StatesFDA openFDA

11listed device types

Class I 6Class II 5Class III 0

plus 11 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

19registered device records

Class IIa 19

BRBrazilANVISA

1registered devices

Class II 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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

21active ARTG entries

Class I 6IIa 15

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 Union23 raw hits, 0 excluded, 23 confirmed

United States11 registration records, 1 510(k), 0 PMA

United Kingdom19 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: Hangzhou Jinlin Medical Appliances Co., Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000012391
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: SUNGO Certification Company Limited

FDA 510(k) clearances by year

12015 · K142764

FDA listed device types

showing 8 of 11

Mask, Oxygen, Low Concentration, Venturi 1Stylet, Tracheal Tube 1Mask, Oxygen, Non-Rebreathing 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1Nebulizer, Medicinal, Non-Ventilatory (Atomizer) 1Catheter And Tip, Suction 1Nebulizer (Direct Patient Interface) 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06946594910155	—	Class IIa
EU	06946594901108	—	Class IIa
EU	06946594901108	—	Class IIa
EU	06946594909494	—	Class IIa
UK	35172	Oxygen Masks	Class IIa
UK	35172	Oxygen Masks	Class IIa
UK	35142	Oxygen Masks	Class IIa
US	K142764	KYOLING CPR Mask with Oxygen Port and Without Oxygen Port	2015-07-09
BR	80488290015	Espaço Morto Lumiar	Class II

Hangzhou Jinlin Medical Appliances 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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