HomeChinaJiangxi Sanxin Medtec Co., Ltd.

Jiangxi Sanxin Medtec Co., Ltd.

China · Nanchang Jiangxi · www.sanxin-med.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000018456Unified social credit code 91360100613026983X

This company holds 72 NMPA certificates in China and has registrations in European Union, United States, Brazil, South Korea, Russia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
72China registrations
Class II 15Class III 56
as of 2026-09-04
EUEuropean UnionEUDAMED
94UDI-DI device records
Class IIa 47Class IIb 47
USUnited StatesFDA openFDA
6listed device types
Class I 0Class II 6Class III 0
plus 5 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
22registered devices
Class I 7Class II 15
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
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
5active registrations
Class 2a 2Class 2b 3
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 Union96 raw hits, 2 excluded, 94 confirmed
United States5 registration records, 5 510(k), 0 PMA
China72 certificates (Class III 56 / II 15 / I 0), as of 2026-09-04
Brazil22 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: JIANGXI SANXIN MEDTEC CO.,LTD. · JIANGXI SANXIN MEDTEC CO., LTD · JIANGXI SANXIN MEDICAL DEVICES GROUP LTD · JIANGXI SANXIN MEDTEC CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000018456
EU authorised representative
Luxus Lebenswelt GmbH
Unified social credit code
91360100613026983X
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Nanchang Jiangxi
Social-insurance enrolees
1,456
Annual revenue
over RMB 500M
Website
www.sanxin-med.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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
1997-03-07
Registered capital
CNY 522,084,275
Paid-in capital
CNY 522,084,275
Legal form
Joint-stock limited company (listed, natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-12-31
Recognitions
National High-Tech EnterpriseGazelle enterpriseRecognised enterprise technology centreTorch Programme enterpriseAbove-designated-size industrial enterprise
Listing
Listed on the A-share market

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

22005 · K050999
12015 · K142797
22021 · K202796

FDA listed device types

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1Syringe, Piston 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Syringe, Antistick 1Mask, Surgical 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253140981预充式导管冲洗器Class III
CN国械注准20253101676血液透析浓缩液Class III
CN国械注准20253100026血液透析浓缩液Class III
CN国械注准20243102289血液透析滤过器Class III
EU06945060593946SansinClass IIa
EU06945060592178SansinClass IIa
EU06945060592161SansinClass IIa
EU06945060592154SansinClass IIa
USK202796SANSIN Tubing Sets for Hemodialysis2021-09-06
USK202719Disposable Medical Face Masks2021-01-04
USK142797I.V. Catheter2015-06-18
BR82179999005Circuitos de sangue de Hemodiálise estéreis para uso único PHARMAZEL PClass II
BR82179999006Circuitos de sangue de Hemodiálise estéreis para uso único PHARMAZEL IClass II
BR82179999007Circuitos de sangue de Hemodiálise estéreis para uso único PHARMAZEL cClass II

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