HomeChinaWeihai Sunway Medical Technology Co., Ltd.

Weihai Sunway Medical Technology Co., Ltd.

China · 威海 · www.sunway-health.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000025939Unified social credit code 91371000334263302J

This company holds 12 NMPA certificates in China and has registrations in European Union, Brazil — 2 overseas markets. EU UDI-DI records ≥295, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
12China registrations
Class I 9Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
≥295UDI-DI device records
Class I 15Class IIa 231IVD A 49
large result set — only the first 300 records were verified, so the real figure is at least this
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
7registered devices
Class I 7
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
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 Union358 raw hits, 5 excluded, 295 confirmed. Large result set — only the first 300 verified
China12 certificates (Class III 0 / II 2 / I 9), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: WEIHAI SUNWAY MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000025939
EU authorised representative
CMC Medical Devices & Drugs SL
Unified social credit code
91371000334263302J
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
89
Annual revenue
RMB 5–10M
Website
www.sunway-health.com
Product categories
临床检验器械及试剂注输、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
2015-05-15
Registered capital
CNY 3,000,000
Paid-in capital
CNY 3,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-12-25
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEGazelle 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鲁械注准20242221066一次性使用采样器Class II
CN鲁械注准20222221075一次性使用静脉血样采集容器Class II
CN鲁威械备20230107一次性使用尿液采集器Class I
CN鲁威械备20230086高分子固定绷带Class I
EU06976556560531Class IIa
EU06976556560425Class IIa
EU06976556560548Class IIa
EU06976556560418Class IIa
BR10379860262FAMÍLIA COLETOR DE URINA COM DISPOSITIVO DE TRANSFERÊNCIAClass I
BR10379860263FAMÍLIA TUBO PARA COLETA DE URINAClass I
BR10379860248FAMÍLIA DE TUBO PARA COLETA DE SANGUE A VÁCUOClass I

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