SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD

Registration Details

Registration Name: SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD
Registration Number: 3006636961
FEI Number: 3006636961
Status: Active
Expiry Year: 2026
Initial Importer: No
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
City: Shenzhen Guangdong
Country: CN

Regulatory Submissions

510(k) Number: K120010

Owner / Operator

Firm Name: Shenzhen Med-Link Electronics Tech Co.,Ltd
Operator Number: 10030237
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
City: Shenzhen
State: Guangdong
Postal Code: 518109
Country: CN
Correspondent: Maolin Ye

US Agent

Business Name: SHARE INFO INC.
Contact Name: Clare Ho
Address: 3557 158th St
City: Flushing
State: NY
ZIP: 11358
Country: US
Email: [email protected]
Phone: 929 4102964

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	Class 2	Cardiovascular	No	2012-01-28
Continuous Measurement Thermometer	FLL	Class 2	General Hospital	No	2026-02-05
System, Measurement, Blood-Pressure, Non-Invasive	DXN	Class 2	Cardiovascular	No	2020-01-06
System, Pressure Measurement, Intermittent	JFC	Class 1	Physical Medicine	No	2024-09-05
Blood Pressure Cuff	DXQ	Class 2	Cardiovascular	No	2018-11-11
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	Class 2	Anesthesiology	No	2024-11-01
Dress, Surgical	FYE	Class 1	General, Plastic Surgery	No	2020-03-26
Electrode, Cutaneous	GXY	Class 2	Neurology	No	2023-02-06
Oximeter	DQA	Class 2	Cardiovascular	No	2009-09-01
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	Class 1	Ophthalmic	No	2020-03-26
Infusor, Pressure, For I.V. Bags	KZD	Class 1	General Hospital	No	2013-09-05
Cable, Electrode	IKD	Class 2	Physical Medicine	No	2021-10-21
Cannula, Nasal, Oxygen	CAT	Class 1	Anesthesiology	No	2026-02-05
Electrode, Electrocardiograph	DRX	Class 2	Cardiovascular	No	2015-01-16
Drain, Tee (Water Trap)	BYH	Class 1	Anesthesiology	No	2021-03-01
Perineometer	HIR	Class 2	Obstetrics/Gynecology	No	2021-10-19
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	Class 2	Gastroenterology, Urology	No	2021-10-19

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 Med-linket disposable Spo2 sensor Goggles Med-link Pulse Oximeter infusor, pressure, for i.v. bags Disposable Pressure Infusion Bag Hylink Med-linket Med-link Temperature Probe Adapter Cable Disposable Gas Sampling Line Reusable and Disposable ECG Electrodes Radiotransparent Leadwires Water Trap Med-link Temperature Probes Med-link Disposable ECG Cable and Leadwires Incontinence probe Pulse Oximeter

Establishment Types

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