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SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066369613006636961SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD1N2026-01-01Zone A of first and second Floor, and third Floor, Building A, N Shanghenglang Community, Dalang Street, Longhua Shenzhen Guangdong CN 518109

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1077911587274129K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)FLL2026-01-08
1077911112010613K220448Disposable Non-invasive EEG SensorGXY2023-01-19
1077911474179149K220447Med-link Disposable ECG Cable and LeadwiresDSA2022-06-28
1077911014381048K212752Med-link Pulse OximeterDQA2022-05-20
1077911613972751K210441Incontinence ProbeKPI2021-09-17
1077911105927027K202743Med-Link Temp-pulse OximeterDQA2021-03-01
1077911422128704K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesFLL2020-08-25
1077911797534955K182667Med-link Temperature ProbesFLL2019-06-18
1077911817627577K181154Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure MonitorDXN2019-08-02
1077911924255484K173869Med-link Reusable Blood Pressure CuffDXQ2018-08-02
1077911395682923K160530Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure CuffDXQ2016-11-28
1077911880797541K120010CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)DSA2012-01-19
1077911187293364K113727SHENZHEN MED-LINK PULSE OXIMETER PROBEDQA2013-03-21
1077912064748123K083010SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSORDQA2009-06-10
1077911093629194
1077911504778939
1077911567594951
1077911141656356
1077911181331307
1077911611527910
1077911614374787
1077911784603601
1077911789187842
1077911790620555
1077911807020841
1077911898874287
1077911934744438

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQA42022-05-20
FLL32026-01-08
DSA22022-06-28
DXQ22018-08-02
GXY12023-01-19
KPI12021-09-17
DXN12019-08-02

GUDID#