HomeChinaJIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO.,LTD

JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO.,LTD

China · 南昌 · www.jxyikang.cn
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000030129Unified social credit code 91360124705600807F

This company holds 32 NMPA certificates in China and has registrations in European Union, United States, Brazil, Taiwan, Australia, Israel, Russia — 7 overseas markets. EU UDI-DI records ≥258, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
32China registrations
Class I 1Class II 16Class III 15
as of 2026-09-04
EUEuropean UnionEUDAMED
≥258UDI-DI device records
Class I 16Class IIa 202Class IIb 40
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
26registered devices
Class II 26
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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 Union564 raw hits, 42 excluded, 258 confirmed. Large result set — only the first 300 verified
United States2 registration records, 2 510(k), 0 PMA, 4 excluded
China32 certificates (Class III 15 / II 16 / I 1), as of 2026-09-04
Brazil26 confirmed, 2 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD. · JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000030129
EU authorised representative
phoenix Medtech GmbH
Unified social credit code
91360124705600807F
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
223
Annual revenue
over RMB 500M
Website
www.jxyikang.cn
Product categories
呼吸、麻醉和急救器械注输、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
1999-01-04
Registered capital
CNY 349,800,000
Paid-in capital
CNY 349,800,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2022-12-27
Recognitions
National High-Tech EnterpriseTechnology-based SMESRDI SMERecognised enterprise technology centreAbove-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

12018 · K173340
12019 · K190213

FDA listed device types

Tube, Tracheal (W/Wo Connector) 1Catheter, Retention Type, Balloon 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263140467一次性使用无菌自毁注射器 带针Class III
CN国械注准20193141042一次性使用精密过滤输液器 带针Class III
CN国械注准20193141041一次性使用精密过滤输液器 带针Class III
CN国械注准20183031790一次性使用无菌心脏二尖瓣球囊扩张导管Class III
EU06949230165087Sterile Intubating Stylets For Single UseClass IIa
EU06949230164929Sterile Intubating Stylets For Single UseClass IIa
EU06949230164912Sterile Intubating Stylets For Single UseClass IIa
EU06949230164974Laryngeal Mask DevicesClass IIa
USK190213Yikang Endotracheal Tube2019-09-06
USK173340Yikang Latex Foley Catheter2018-07-13
BR82225699001Sonda Foley FanomedClass II
BR82225699002Sonda Uretral FanomedClass II
BR82225699003Sonda Foley Silicone FanomedClass II

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