HomeChinaShenzhen Welld Medical Electronics Co., Ltd.

Shenzhen Welld Medical Electronics Co., Ltd.

China · 深圳 · www.welld.com.cn
✓ Record-verifiedregistrations found in 3 marketsUnified social credit code 91440300192408579C

This company holds 11 NMPA certificates in China and has registrations in United States, Russia — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
11China registrations
Class II 11
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 2 510(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
1active registrations
Class 2a 1
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 Union3 raw hits, 3 excluded, 0 confirmed
United States2 registration records, 2 510(k), 0 PMA, 36 excluded
China11 certificates (Class III 0 / II 11 / I 0), as of 2026-09-04
Manufacturer names merged into this page: WELL MEDICAL

Regulatory identity

Unified social credit code
91440300192408579C
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
129
Annual revenue
RMB 100–500M
Website
www.welld.com.cn
Product categories
医用影像

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
1996-01-19
Registered capital
CNY 150,000,000
Paid-in capital
CNY 150,000,000
Legal form
Limited liability company (wholly corporate-owned)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2022-07-26
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative SME

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

12010 · K100079
12018 · K182165

FDA listed device types

Accessories, Implant, Dental, Endosseous 1Handpiece, Direct Drive, Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20212061460便携式全数字彩色多普勒超声诊断系统Class II
CN粤械注准20212061349超声引导系统Class II
CN粤械注准20212060701彩色多普勒超声系统Class II
CN粤械注准20192060298全数字彩色多普勒超声诊断系统Class II
USK182165Color Doppler Ultrasound System; Model: mEye1 and mEye22018-12-20
USK100079DIGITAL ULTRASOUND SCANNER2010-03-01

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