HomeChinaJIANERKANG MEDICAL CO., LTD

JIANERKANG MEDICAL CO., LTD

China · Changzhou Jiangsu · www.chinajek.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000011206Unified social credit code 91320413714946201R

This company holds 103 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Saudi Arabia, Taiwan, South Korea, Australia, Israel — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
103China registrations
Class I 51Class II 51Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
27UDI-DI device records
Class I 19Class IIa 8
USUnited StatesFDA openFDA
18listed device types
Class I 12Class II 4Class III 0unclassified 2
plus 22 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
16registered device records
Class I 14Class IIa 2
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
6registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
6active ARTG entries
Class I 3IIa 1IIb 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 Union27 raw hits, 0 excluded, 27 confirmed
United States22 registration records, 4 510(k), 0 PMA
China103 certificates (Class III 1 / II 51 / I 51), as of 2026-09-04
United Kingdom16 confirmed, 0 excluded
Saudi Arabia6 confirmed, 0 excluded
Manufacturer names merged into this page: JIANERKANG MEDICAL CO., LTD. · Jiangsu Province Jianerkang Medical Dressing Co Ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000011206
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Wellkang Ltd
Unified social credit code
91320413714946201R
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Changzhou Jiangsu
Social-insurance enrolees
1,209
Annual revenue
RMB 50–100M
Website
www.chinajek.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2000-06-06
Registered capital
CNY 156,000,000
Paid-in capital
CNY 156,000,000
Legal form
Joint-stock limited company (listed)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-10-11
Recognitions
National High-Tech EnterprisePrivate technology enterpriseAbove-designated-size industrial enterprise
Listing
Listed on the A-share market

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12012 · K112110
12020 · K202061
12021 · K210215
12023 · K232957

FDA listed device types

showing 8 of 18
Anti Fog Solution And Accessories, Endoscopy 1Tubing, Noninvasive 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Media, Coupling, Ultrasound 1Bandage, Cast 1Gauze / Sponge,Nonresorbable For External Use 1Lubricant, Patient 1Gauze/Sponge, Internal, X-Ray Detectable 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20203140647聚氨酯泡沫敷料Class III
CN苏械注准20252080141医用氧气湿化装置Class II
CN苏械注准20242171663口腔溃疡含漱液Class II
CN苏械注准20242141568医用护理垫Class II
EU06921865504295JIANERKANG STERILE FACE MASKClass I
EU06921865504042STERILE GAUZE SWAB WITH XRClass IIa
EU06921865504035STERILE GAUZE SWAB WITH XRClass IIa
EU06921865504028STERILE LAP SPONGEClass IIa
UK13913Alcohol SwabsticksClass I
UK13913Alcohol SwabsticksClass I
UK58232Absorbent cottonClass I
USK232957Sterile and Non-Sterile Ultrasound Gels2023-12-15
USK210215Surgical Gowns2021-07-07
USK202061Medical Face mask2020-12-23
SAME0000009089SFDAA00001ALCOHOL SWABSTICKS 3 ea
SAME0000009089SFDAA00002ALCOHOL SWABSTICKS 1 ea

Similar companies

Allmed Medical Products Co. Ltd.
China · markets 12
Anhui Hongyu Wuzhou Medical Manufacturer Co.,
China · markets 7
ANHUI KONZERN PACKAGE MATERIAL CO.,LTD
China · markets 4
Anhui Micoom Medical Packaging Co.,Ltd
China · markets 3
Anhui Monique Medical Material CO.,LTD
China · markets 3
Anhui Tianrun Medical Packaging Materials Co.
China · markets 4
Is this your company? Claim the page, add information or report a data error.Claim / report an error →