HomeChinaShenzhen YIWEI Medical Technology Co.,Ltd

Shenzhen YIWEI Medical Technology Co.,Ltd

China · 深圳 · www.drbrain.net/index.aspx
✓ Record-verifiedregistrations found in 2 marketsEU SRN CN-MF-000057694

This company has registrations in European Union, United States — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
12UDI-DI device records
Class I 12
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 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
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 Union12 raw hits, 0 excluded, 12 confirmed
United States1 registration records, 1 510(k), 0 PMA
Manufacturer names merged into this page: YIWEI MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000057694
EU authorised representative
Crealkraft GmbH
Exhibition record
Rehab & Elderly Care Expo (Spring 2026, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
0
Website
www.drbrain.net/index.aspx
Product categories
医用康复器械

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
2017-03-16
Registered capital
CNY 1,134,430
Paid-in capital
CNY 79,140
Legal form
Joint-stock limited company (unlisted)
Industry classification
Technology promotion and application services
Last approval date
2026-08-28
Recognitions
Micro and small enterpriseManufacturing Single ChampionInnovative SME

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

12023 · K213891

FDA listed device types

Computerized Cognitive Assessment Aid, Exempt 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06974782410217VR Attention Assessment and Rehab Training SystemClass I
EU06974782410224VR Attention Assessment and Rehab Training SystemClass I
EU06974782410231VR Attention Assessment and Rehab Training SystemClass I
EU06974782410194VR Cognitive Assessment and Rehab Training SystemClass I
USK213891RealNow2023-02-24

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