HomeChinaShenzhen Medke Technology Co., Ltd

Shenzhen Medke Technology Co., Ltd

China · 深圳 · www.medke.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000019638Unified social credit code 91440300683788713H

This company holds 9 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel, Russia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
9China registrations
Class I 4Class II 5
as of 2026-09-04
EUEuropean UnionEUDAMED
36UDI-DI device records
Class I 20Class IIb 16
USUnited StatesFDA openFDA
4listed device types
Class I 0Class II 4Class III 0
plus 4 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
6registered device records
Class I 4Class IIb 2
BRBrazilANVISA
5registered devices
Class I 3Class II 2
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
8active ARTG entries
Class I 4IIa 1IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
3active registrations
Class 1 1Class 2b 2
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 Union54 raw hits, 18 excluded, 36 confirmed
United States4 registration records, 3 510(k), 0 PMA
China9 certificates (Class III 0 / II 5 / I 4), as of 2026-09-04
United Kingdom6 confirmed, 1 excluded
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN MEDKE TECHNOLOGY CO., LTD. · SHENZHEN MEDKE TECHNOLOGY CO. LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000019638
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
UK responsible person
MedPath Limited
Unified social credit code
91440300683788713H
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
113
Annual revenue
RMB 50–100M
Website
www.medke.com
Product categories
医用传感配件

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
2008-12-24
Registered capital
CNY 10,000,000
Paid-in capital
CNY 2,000,000
Legal form
Limited liability company
Industry classification
Computer, communications and other electronic equipment
Last approval date
2026-08-10
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

12016 · K152390
12024 · K242623
12025 · K243000

FDA listed device types

Continuous Measurement Thermometer 1Blood Pressure Cuff 1Cable, Electrode 1Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20232070034重复性血氧探头Class II
CN粤械注准20232070033一次性血氧探头Class II
CN粤械注准20222071653一次性体温探头Class II
CN粤械注准20222071618重复性体温探头Class II
EU06971018115427Patient cables and Lead wiresClass I
EU06971018116899Patient cables and Lead wiresClass I
EU06971018118893Patient cables and Lead wiresClass I
EU06971018117049Patient cables and Lead wiresClass I
UK34978NIBP CuffClass I
UK37326NIBP CuffClass I
UK35562ECG CableClass I
USK243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)2025-06-20
USK242623Disposable Blood Pressure cuff; Reusable Blood Pressure cuff2024-10-31
USK152390Medke Oximetry Finger Sensor2016-08-18
BR82597650003ELETRODO PRECORDIAL COM PERA EM SILICONE - MORAMEDClass I
BR82384159001Sensor de Temperatura ReutilizávelClass II
BR82597650002ELETRODO PARA ECGClass I

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