HomeChinaChangzhou shuangma medical devices co.,ltd

Changzhou shuangma medical devices co.,ltd

China · 常州 · www.shuangma-china.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000009732Unified social credit code 913204027185820037

This company holds 12 NMPA certificates in China and has registrations in European Union, Brazil, South Korea, Australia, Hong Kong, Israel, Russia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
12China registrations
Class I 1Class II 4Class III 7
as of 2026-09-04
EUEuropean UnionEUDAMED
173UDI-DI device records
Class I 52Class IIa 121
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
2registered devices
Class II 2
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
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
7active ARTG entries
Class I 4IIa 3
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 Union173 raw hits, 0 excluded, 173 confirmed
China12 certificates (Class III 7 / II 4 / I 1), as of 2026-09-04
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: CHANGZHOU SHUANGMA MEDICAL DEVICER CO., LTD · CHANGZHOU SHUANGMA MEDICAL DEVICES CO., LTDA

Regulatory identity

EU manufacturer SRN
CN-MF-000009732
EU authorised representative
Llins Service & Consulting GmbH
Unified social credit code
913204027185820037
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
110
Annual revenue
RMB 100–500M
Website
www.shuangma-china.com
Product categories
注输、护理和防护器械妇产科、辅助生殖和避孕器械

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
1999-12-02
Registered capital
CNY 11,580,000
Paid-in capital
CNY 11,580,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-07-16
Recognitions
Micro and small enterpriseNational High-Tech 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20163141787一次性使用输液器 带针Class III
CN国械注准20163141786一次性使用精密过滤输液器 带针Class III
CN国械注准20153141156一次性使用静脉输液针Class III
CN国械注准20153141155一次性使用无菌注射针Class III
EU06945144711945Siringhe latex freeClass IIa
EU06945144711938Siringhe latex freeClass IIa
EU06945144711921Siringhe latex freeClass IIa
EU06945144711914Siringhe latex freeClass IIa
BR80451960102NPH MEDICAL BOLSA COLETORA DE URINA DESCARTÁVEL SISTEMA FECHADO ESTÉRIClass II
BR80451960031NPH MEDICAL ESCALPE - DISPOSITIVO DE INFUSÃO INTRAVENOSAClass II

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