HomeChinaShenzhen MedLink Electronics Tech Co., Ltd.

Shenzhen MedLink Electronics Tech Co., Ltd.

China · Shenzhen · www.med-linket.com
✓ Record-verifiedregistrations found in 9 marketsUnified social credit code 91440300758612510W

This company holds 36 NMPA certificates in China and has registrations in United States, Brazil, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 8 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
36China registrations
Class I 5Class II 31
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
18listed device types
Class I 6Class II 12Class III 0
plus 24 registration records and 14 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
34registered devices
Class I 16Class II 18
36 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
8 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 6
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
8registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 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 Union6 raw hits, 6 excluded, 0 confirmed
United States24 registration records, 14 510(k), 0 PMA, 22 excluded
China36 certificates (Class III 0 / II 31 / I 5), as of 2026-09-04
Brazil34 confirmed, 5 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD · SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. · ShenZhen Med-Link Electronics Tech Co.,Ltd · SHENZHEN MED-LINK ELETRONICS TECH CO. LTD · SHENZHEN MED-LINK ELETRONICS TECH CO.,LTD

Regulatory identity

Unified social credit code
91440300758612510W
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Shenzhen
Social-insurance enrolees
346
Annual revenue
RMB 100–500M
Website
www.med-linket.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systems

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
2004-02-17
Registered capital
CNY 40,800,000
Paid-in capital
CNY 39,501,660
Legal form
Joint-stock limited company (unlisted)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-01-15
Recognitions
National High-Tech EnterpriseAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

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

12009
12012
12013
12016
12018
22019
12020
22021
22022
12023
12026

FDA listed device types

showing 8 of 18
Electrosurgical, Cutting & Coagulation & Accessories 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Cable, Electrode 1System, Measurement, Blood-Pressure, Non-Invasive 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Perineometer 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20262080075呼气末二氧化碳采集鼻氧管Class II
CN粤械注准20262070365一次性医用针电极Class II
CN粤械注准20252071543一次性使用无菌心电导联线Class II
CN粤械注准20252071502一次性无菌血压袖带Class II
USK251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)2026-01-08
USK220448Disposable Non-invasive EEG Sensor2023-01-19
USK220447Med-link Disposable ECG Cable and Leadwires2022-06-28
BR80415619005SENSOR DE EEGClass II
BR81470729010Sensor EEG de Índice Bispectral (BIS) para Monitoração AnestésicaClass II
BR80415610031BRAÇADEIRA PARA AFERIÇÃO DA PRESSÃO ARTERIAL NÃO INVASIVA NYLON HYLINKClass I

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