Home›China›Suzhou Weikang Medical Apparatus Co., Ltd.

Suzhou Weikang Medical Apparatus Co., Ltd.

China · Suzhou Jiangsu · www.wkmedical.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000002179

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, 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

109UDI-DI device records

Class I 2Class IIa 107

USUnited StatesFDA openFDA

18listed device types

Class I 10Class II 8Class III 0

plus 34 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

6registered device records

Class IIa 6

BRBrazilANVISA

1registered devices

Class 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

10 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IIa 3IIb 1Class Is (sterile) 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 Union122 raw hits, 13 excluded, 109 confirmed

United States34 registration records, 2 510(k), 0 PMA, 1 excluded

United Kingdom6 confirmed, 1 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD. · JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO. LTD · Jiangsu Weikang Jiejing Medical Apparatus Co.,Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000002179
EU authorised representative: SUNGO Europe B.V.
UK responsible person: SUNGO Certification Company Limited

FDA 510(k) clearances by year

12014 · K140228

12015 · K140237

FDA listed device types

showing 8 of 18

Trap, Sterile Specimen 1Catheter And Tip, Suction 1Nebulizer (Direct Patient Interface) 1Collector, Urine, (And Accessories) For Indwelling Catheter 1Tubes, Gastrointestinal (And Accessories) 1Tube, Tracheal (W/Wo Connector) 1Tubing, Noninvasive 1Tube, Aspirating, Flexible, Connecting 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06970304311642	Disposable Suction Connecting Tube FFM	Class IIa
EU	06970304316289	suction tube combo	Class IIa
EU	06970304316081	nebulizer mask	Class IIa
EU	06970304316074	nebulizer	Class IIa
UK	10749	Disposable Suction Catheters	Class IIa
UK	46967	Disposable Tracheal Tubes	Class IIa
UK	35201	Disposable Nasal Oxygen Cannulae	Class IIa
US	K140237	DISPOSABLE NEBULIZER SET	2015-01-08
US	K140228	DISPOSABLE TRACHEAL TUBE	2014-12-18
BR	80137019002	Sonda de aspiração - sistema fechado	Class II
SA	ME0000013199SFDAA00011	SUNSET	—

Suzhou Weikang Medical Apparatus 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)

Similar companies