HomeChinaShenZhen ZhengKang Technology Co., Ltd.

ShenZhen ZhengKang Technology Co., Ltd.

China · 深圳 · www.sz-zk.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000038997Unified social credit code 91440300083893368H

This company holds 12 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Canada — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
12China registrations
Class I 1Class II 11
as of 2026-09-04
EUEuropean UnionEUDAMED
13UDI-DI device records
Class IIa 13
USUnited StatesFDA openFDA
5listed device types
Class I 0Class II 5Class III 0
plus 5 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 1
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
10 including historic records
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 Union267 raw hits, 254 excluded, 13 confirmed
United States5 registration records, 3 510(k), 0 PMA, 1 excluded
China12 certificates (Class III 0 / II 11 / I 1), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000038997
EU authorised representative
Lotus NL B.V.
UK responsible person
Wellkang Ltd
Unified social credit code
91440300083893368H
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
40
Annual revenue
RMB 50–100M
Website
www.sz-zk.com
Product categories
医用诊察和监护器械

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
2013-11-15
Registered capital
CNY 10,000,000
Paid-in capital
CNY 4,100,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2024-03-04
Recognitions
Micro and small 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.

FDA 510(k) clearances by year

12020 · K191894
12021 · K203707
12022 · K213984

FDA listed device types

System, Measurement, Blood-Pressure, Non-Invasive 1Oximeter, Infrared, Sporting, Aviation 1Oximeter 1Thermometer Kit 1Continuous Measurement Thermometer 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262400343血糖试纸(葡萄糖脱氢酶法)Class II
CN粤械注准20262070227臂式电子血压计Class II
CN粤械注准20242220230血糖仪Class II
CN粤械注准20232180074超声多普勒胎儿心率仪Class II
EU06922119301387Upper Arm Blood Pressure MonitorClass IIa
EU06922119301370Upper Arm Blood Pressure MonitorClass IIa
EU06922119301363Upper Arm Blood Pressure MonitorClass IIa
EU06922119301356Upper Arm Blood Pressure MonitorClass IIa
UK45617Upper Arm Blood Pressure MonitorClass IIa
USK213984Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)2022-12-16
USK203707Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-6032021-03-12
USK191894Upper Arm Blood Pressure Monitor2020-02-21

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