Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006636961

FEI Number

3006636961

Entity Name

SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Zone A of first and second Floor, and third Floor, Building A, No. seven, Tongsheng Industrial Park Road, Shanghenglang Community, Dalang Street, Longhua District, Shenzhen Guangdong 518109, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Shenzhen Med-Link Electronics Tech Co.,Ltd (Owner Number: 10030237)

Owner / Operator Contact Address

Zone A of first and second Floor, and third Floor, Building A, No. seven, Tongsheng Industrial Park Road, Shanghenglang Community, Dalang Street, Longhua District, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160530

PMA Number

N/A

All Registered Proprietary Names

Med-Linket Sterile Temperature Probe Sterile temperature probe-W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0001QS, W0001FS, W0001PS, W0001LS Med-link Wrist Digital Blood Pressure Monitor Med-link Upper Arm Digital Blood Pressure Monitor Interconnect tube Med-link Reusable Blood Pressure Cuff HUMIDIFIER, RESPIRATORY GAS Med-link Disposable Temperature Probes Med-link Reusable Temperature Probes Protective Face Shield Disposable Non-invasive EEG Sensor MED-LINKET MED-LINKET Reusable Spo2 Sensor S0005B-L S0005C-L S0005D-L S0005P-L S0005F-L S0005I-L MED-LINKET Reusable Spo2 Sensor S0005B-S S0005C-S S0005D-S S0005P-S S0005E-S S0005F-S S0005G-S S0005I-S Pulse Oximeter Probe Med-linket Oximeter disposable sensor MED-LINKET Disposable Spo2 Sensor S0005J-S S0005K-S S0005L-L S0005M-L S0005N-L Pulse Oximeter Probe Med-linket disposable Spo2 sensor Goggles Med-link Pulse Oximeter infusor, pressure, for i.v. bags Disposable Pressure Infusion Bag Hylink Med-linket

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2012-01-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-02-05
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-01-06
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	Class 1	890.1600	2024-09-05
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2018-11-11
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-11-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-09-17
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-26
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-02-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-09-01
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-04-11
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-03-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-03-08
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2013-09-05
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2016-11-28

Official Correspondent

Maolin Ye

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Shenzhen Med-Link Electronics Tech Co.,Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880323	Medtronic Vascular	MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR	1988-03-22
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006636961. Last updated year: 2026. Please use registration number 3006636961 when referencing this establishment in official correspondence.