HomeChinaSuzhou Shenyun Medical Equipment Co., Lt

Suzhou Shenyun Medical Equipment Co., Lt

China · Suzhou Jiangsu · shenyunmedical.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000026847Unified social credit code 91320506MA2289G7X0

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, Saudi Arabia — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class I 1Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
68UDI-DI device records
Class I 23Class IIa 45
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered 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
pendingnot queried
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 Union68 raw hits, 0 excluded, 68 confirmed
United States0 registration records, 1 510(k), 0 PMA
China5 certificates (Class III 0 / II 4 / I 1), as of 2026-09-04
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: Suzhou Shenyun Medical Equipment Co., Ltd.

Regulatory identity

EU manufacturer SRN
CN-MF-000026847
EU authorised representative
MedPath GmbH
Unified social credit code
91320506MA2289G7X0
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
City
Suzhou Jiangsu
Social-insurance enrolees
17
Annual revenue
RMB 50–100M
Website
shenyunmedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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
2020-08-18
Registered capital
CNY 5,000,000
Paid-in capital
CNY 200,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2022-07-02
Recognitions
Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-03. 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

12026 · K260197

Registration details (sample)

MarketIdentifierNameClass / date
CN苏械注准20252141737一次性使用外科手术引流导管套装Class II
CN苏械注准20252021373一次性腹壁缝合器套件Class II
CN苏械注准20242140459一次性使用胃管Class II
CN苏械注准20232141554一次性使用胃管Class II
EU06975573322092SHENYUN MEDICAL Sterile Single Use Drainage TubeClass IIa
EU06975573322085SHENYUN MEDICAL Sterile Single Use Drainage TubeClass IIa
EU06975573322078SHENYUN MEDICAL Sterile Single Use Drainage TubeClass IIa
EU06975573322061SHENYUN MEDICAL Sterile Single Use Drainage TubeClass IIa
USK260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)2026-04-08
SAME0000004445SFDAA00002Calibration tube

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