HomeChinaSYSMED(CHINA)CO.,LTD.

SYSMED(CHINA)CO.,LTD.

China · 沈阳 · www.sysmed.cn
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000011904Unified social credit code 91210100001613431A

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
5China registrations
Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
4UDI-DI device records
Class IIa 4
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
1registered devices
Class II 1
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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 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 Union4 raw hits, 0 excluded, 4 confirmed
United States2 registration records, 2 510(k), 0 PMA
China5 certificates (Class III 0 / II 5 / I 0), as of 2026-09-04
Brazil1 confirmed, 1 excluded
Manufacturer names merged into this page: SYSMED (CHINA) CO., LTD · SYSMED (CHINA) CO.,LTD. · SYSMED (CHINA) CO. LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000011904
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91210100001613431A
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
147
Annual revenue
RMB 30–50M
Website
www.sysmed.cn

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
2000-11-27
Registered capital
CNY 101,180,000
Paid-in capital
CNY 101,180,000
Legal form
Joint-stock limited company (unlisted, state-controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2022-07-28
Recognitions
National High-Tech EnterpriseTechnology-based SMERecognised enterprise technology centreAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

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 · K172234
12020 · K192177

FDA listed device types

Generator, Oxygen, Portable 1Ventilator, Non-Continuous (Respirator) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN辽械注准20242080030正压通气治疗机Class II
CN辽械注准20232080013正压通气治疗机Class II
CN辽械注准20222080085医用分子筛制氧机Class II
CN辽械注准20172080137医用氧气机Class II
EU06955623000101Oxygen Concentrator for Medical useClass IIa
EU06955623000194OC-E100Class IIa
EU06955623000033oxygen concentratorClass IIa
EU06955623000361oxygen concentratorClass IIa
USK192177SysMed S/T2020-11-25
USK172234Oxygen Concentrator2018-06-01
BR10317700019CONCENTRADOR DE OXIGÊNIO OT SYSMEDClass II

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