HomeChinaJiangsu Kangle Medical Device Co., Ltd.

Jiangsu Kangle Medical Device Co., Ltd.

China · 盐城 · www.comluckmedical.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000041147Unified social credit code 9132092459393326XL

This company holds 24 NMPA certificates in China and has registrations in European Union, Brazil, Australia — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
24China registrations
Class I 7Class II 16Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
177UDI-DI device records
Class IIa 177
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 Union177 raw hits, 0 excluded, 177 confirmed
China24 certificates (Class III 1 / II 16 / I 7), as of 2026-09-04
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: JIANGSU KANGLE MEDICAL DEVICE CO.,LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000041147
EU authorised representative
HUMISS TRADING S. L.
Unified social credit code
9132092459393326XL
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
89
Annual revenue
RMB 50–100M
Website
www.comluckmedical.com
Product categories
手术室及急救医用耗材医用影像

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
2012-04-12
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Other manufacturing
Last approval date
2025-01-24
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20183060305一次性使用高压造影注射器及附件Class III
CN苏械注准20232080536可视软性喉镜Class II
CN苏械注准20232080500可视麻醉喉镜Class II
CN苏械注准20202080541一次性使用麻醉喉镜窥视片Class II
EU06937137118091Class IIa
EU06937137118084Class IIa
EU06937137118077Class IIa
EU06937137118060Class IIa
BR82441209052Kit Seringa de Alta Pressão ComLuckClass II

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