HomeChinaJiangsu Kangyou medical instrument co.,ltd

Jiangsu Kangyou medical instrument co.,ltd

China · 常州
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000027474Unified social credit code 91320413137388683F

This company holds 22 NMPA certificates in China and has registrations in European Union, United States, Brazil, Australia, Russia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
22China registrations
Class I 3Class II 5Class III 14
as of 2026-09-04
EUEuropean UnionEUDAMED
29UDI-DI device records
Class I 7Class IIa 22
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
6registered devices
Class I 1Class II 5
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 Union223 raw hits, 194 excluded, 29 confirmed
United States0 registration records, 1 510(k), 0 PMA
China22 certificates (Class III 14 / II 5 / I 3), as of 2026-09-04
Brazil6 confirmed, 1 excluded
Manufacturer names merged into this page: JIANGSU KANGYOU MEDICAL INSTRUMENTS CO.,LTD. · JIANGSU KANGYOU MEDICAL INSTRUMENT CO LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000027474
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91320413137388683F
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
152
Annual revenue
RMB 50–100M
Product categories
医用耗材输血及体外循环体外诊断注输、护理和防护器械

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
2002-04-12
Registered capital
CNY 13,080,000
Paid-in capital
CNY 13,080,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Professional technical services
Last approval date
2022-06-18
Recognitions
Micro and small enterpriseAbove-designated-size industrial enterprise

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

12021 · K211728

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20223140589一次性使用无菌胰岛素注射器Class III
CN国械注准20213141066一次性使用静脉营养输液袋Class III
CN国械注准20183140302一次性使用输液器 带针Class III
CN国械注准20183140301一次性使用精密过滤输液器 带针Class III
EU16944425880636Sterile Insulin Syringes for Single UseClass IIa
EU16944425880643Sterile Insulin Syringes for Single UseClass IIa
EU16944425880599Sterile Insulin Syringes for Single UseClass IIa
EU16944425880438Sterile Insulin Syringes for Single UseClass IIa
USK211728Sterile hypodermic syringes for single use2021-10-05
BR82159199011AgulhaClass II
BR82159199012Seringas DescartáveisClass II
BR82159199013Seringas Descartáveis com agulhaClass II

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