HomeChinaWuhan Zoncare Bio-Medical Electronics Co., Ltd.

Wuhan Zoncare Bio-Medical Electronics Co., Ltd.

China · Wuhan Hubei · en.zoncare.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000010439Unified social credit code 914201007713533308

This company holds 35 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Hong Kong, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
35China registrations
Class I 1Class II 34
as of 2026-09-04
EUEuropean UnionEUDAMED
40UDI-DI device records
Class I 1Class IIa 39
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 2
BRBrazilANVISA
7registered devices
Class II 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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
4active registrations
Class 2a 3Class 2b 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 Union40 raw hits, 0 excluded, 40 confirmed
United States0 registration records, 1 510(k), 0 PMA
China35 certificates (Class III 0 / II 34 / I 1), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: WUHAN ZONCARE BIO-MEDICAL ELECTRONICS CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000010439
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
Wellkang Ltd
Unified social credit code
914201007713533308
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Wuhan Hubei
Social-insurance enrolees
413
Annual revenue
RMB 100–500M
Website
en.zoncare.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsUltrasound (POCUS, AI-guided, portable)

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
2005-01-31
Registered capital
CNY 50,000,000
Paid-in capital
CNY 50,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-10-24
Recognitions
National High-Tech EnterpriseSRDI SMEGazelle enterpriseRecognised enterprise technology centreHidden champion

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

12019 · K183041

Registration details (sample)

MarketIdentifierNameClass / date
CN鄂械注准20262066000彩色多普勒超声系统Class II
CN鄂械注准20252075929动态血压监测仪Class II
CN鄂械注准20242075197动态心电血压记录仪Class II
CN鄂械注准20242075187数字式十二道心电图机Class II
EU06956913490220ZONCAREClass IIa
EU06956913490213ZONCAREClass IIa
EU06956913490206ZONCAREClass IIa
EU06956913490190ZONCAREClass IIa
UK16231Digital Multi-channel ElectrocardiographClass IIa
UK40761i Series All-Digital Ultrasound Diagnostic SystemClass IIa
USK183041Full Digital Colour Doppler Ultrasonic Diagnostic System2019-07-10
BR82205419030Eletrocardiógrafo ZONCARE iMAC1800PROClass II
BR82205419026Eletrocardiógrafo ZONCARE E12Class II
BR82205419027Eletrocardiógrafo ZONCARE E30Class II

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