HomeChinaJIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD.

China · 泰州 · www.kangjian.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000018938Unified social credit code 91321204704012923D

This company holds 34 NMPA certificates in China and has registrations in European Union, United States, Brazil, Australia, Israel, Russia — 6 overseas markets. EU UDI-DI records ≥264, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
34China registrations
Class I 25Class II 8Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
≥264UDI-DI device records
Class I 8IVD A 256
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
19listed device types
Class I 17Class II 2Class III 0
plus 21 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
31registered devices
Class I 31
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
5active ARTG entries
Class I 1IVD Class 1 2Class Is (sterile) 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
3active registrations
Class 1 1Class 2a 2
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 Union564 raw hits, 36 excluded, 264 confirmed. Large result set — only the first 300 verified
United States21 registration records, 0 510(k), 0 PMA, 1 excluded
China34 certificates (Class III 1 / II 8 / I 25), as of 2026-09-04
United Kingdom0 confirmed, 3 excluded
Brazil31 confirmed, 1 excluded
Manufacturer names merged into this page: JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD. · JIANGSU KANGJIAN MEDICAL APPARATUS CO. LTD. · JIANGSU KANGJIAN MEDICAL APPARATUS CO. LTD. · JIANGSU KANGJIAN MEDICAL APPARATUS CO LTD · JIANGSU KANGJIAN MEDICAL APPARATUS CO., LTD. - · Jiangsu Kangjian Medical Apparatus Co., Ltd Ms.

Regulatory identity

EU manufacturer SRN
CN-MF-000018938
EU authorised representative
Zoustech S.L.
Unified social credit code
91321204704012923D
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
342
Annual revenue
RMB 100–500M
Website
www.kangjian.com

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
1993-02-15
Registered capital
CNY 108,000,000
Paid-in capital
CNY 108,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2022-12-14
Recognitions
Micro and small enterpriseNational High-Tech EnterprisePrivate technology enterpriseSRDI SME

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 listed device types

showing 8 of 19
Container, Specimen, Sterile 1Dress, Surgical 1Centrifuge, Blood-Bank For In Vitro Diagnostic Use 1Container, Specimen Mailer And Storage, Sterile 1Container, Specimen, Non-Sterile 1Pipette, Pasteur 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Micro Pipette 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20193220570一次性使用静脉采血针Class III
CN苏械注准20262180833辅助生殖用样品杯Class II
CN苏械注准20262180824辅助生殖用试管Class II
CN苏械注准20262180356辅助生殖用培养皿Class II
EU06953211309186Class I
EU06953211308776Class I
EU06953211308691Class I
EU06953211378540IVD A
BR81649660003Centrífugas CMBClass I
BR80638720145CENTRÍFUGA BIOCONClass I
BR80680250014Escova Cervical GynoPrepClass I

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