HomeChinaJiangsu Kangbao Medical Equipment Co.,Ltd

Jiangsu Kangbao Medical Equipment Co.,Ltd

China · 扬州 · www.medkb.cn
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000025682Unified social credit code 913210237494457651

This company holds 24 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
24China registrations
Class I 4Class II 16Class III 4
as of 2026-09-04
EUEuropean UnionEUDAMED
15UDI-DI device records
Class I 8Class IIa 7
USUnited StatesFDA openFDA
10listed device types
Class I 4Class II 6Class III 0
plus 10 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 2
BRBrazilANVISA
60registered devices
Class I 16Class II 44
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
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 1Manufacturing 1
AUAustraliaTGA ARTG
4active ARTG entries
IIa 3Class Is (sterile) 1
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
3registrations
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 Union75 raw hits, 60 excluded, 15 confirmed
United States10 registration records, 5 510(k), 0 PMA
China24 certificates (Class III 4 / II 16 / I 4), as of 2026-09-04
United Kingdom2 confirmed, 1 excluded
Brazil60 confirmed, 1 excluded
Manufacturer names merged into this page: JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD · JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD., · JIANGSU KANGBAO MEDICAL EQUIPAMENTOS CO., LTD · JIANGSU KANGBAO MEDICAL EQUIPMENT CO. LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000025682
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
913210237494457651
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
272
Annual revenue
over RMB 500M
Website
www.medkb.cn
Product categories
医用耗材注输、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
2003-06-06
Registered capital
CNY 22,500,000
Paid-in capital
CNY 22,500,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-06-10
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEInnovative 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 510(k) clearances by year

12018 · K182649
12020 · K192681
12021 · K211329
12022 · K221247
12023 · K232881

FDA listed device types

showing 8 of 10
Syringe, Piston 1Syringe, Antistick 1Enteral Syringes With Enteral Specific Connectors 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1System, Blood Collection, Vacuum-Assisted, Manual 1Instrument, Manual, Surgical, General Use 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20173144590一次性使用无菌注射针Class III
CN国械注准20173144571一次性使用无菌注射器 带针Class III
CN国械注准20173144567一次性使用输液器 带针Class III
CN国械注准20173144566一次性使用静脉输液针Class III
EU06971028716096Sterile Hypodermic Syringes for single useClass IIa
EU06971028716188Sterile Hypodermic Needle for Single UseClass IIa
EU06971028716171Sterile Hypodermic Needle for Single UseClass IIa
EU06971028716195Sterile Hypodermic Needle for Single UseClass IIa
UK65416Product Name: Scalp Vein Needle for Single Use Trade Name: The Butterfly Needle for Single UseClass IIa
UK60643Product Name:Sterile Safety Syringe for Single Use Trade Name:Sterile single use 1ml Low Dead Space Syringe with fixed safety needleClass IIa
USK232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder2023-12-22
USK221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle2022-11-01
USK211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle2021-11-15
BR81788089028Agulha Hipodérmica Estéril com Dispositivo de Segurança ABLClass II
BR82792480002SERINGA ENTERAL ESTÉRIL ENFIT – GS INTERNATIONALClass I
BR82792489001EQUIPO DE NUTRIÇÃO ENTERAL COM CONECTOR ENFIT – GS INTERNATIONALClass II

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