HomeChinaWistron Medical Technology Corporation

Wistron Medical Technology Corporation

China · 重庆 · www.keeogo-china.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN TW-MF-000028594Unified social credit code 91500000MA5U7MWEX2

This company holds 2 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
2China registrations
Class I 1Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
1UDI-DI device records
Class I 1
USUnited StatesFDA openFDA
4listed device types
Class I 0Class II 4Class III 0
plus 3 registration records and 0 510(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 Union1 raw hits, 0 excluded, 1 confirmed
United States3 registration records, 0 510(k), 0 PMA, 1 excluded
China2 certificates (Class III 0 / II 1 / I 1), as of 2026-09-04
Manufacturer names merged into this page: WISTRON MEDICAL TECHNOLOGY CORPORATION

Regulatory identity

EU manufacturer SRN
TW-MF-000028594
EU authorised representative
Luana Med. B.V.
Unified social credit code
91500000MA5U7MWEX2
Exhibition record
Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
0
Annual revenue
under RMB 5M
Website
www.keeogo-china.com
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
2016-09-14
Registered capital
USD 5,900,000
Paid-in capital
USD 3,000,000
Legal form
Limited liability company (wholly owned by a foreign corporation)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-01-09
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 listed device types

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1Wearable Vibration Device For Orthopedic Use 1Calculator, Drug Dose 1

Registration details (sample)

MarketIdentifierNameClass / date
CN渝械注准20232190055步态训练系统Class II
CN渝械备20180083号下肢固定器Class I
EU04719892330015BestShapeClass I

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