Data / Medical devices / China / Shenzhen Med-Link Electronics Tech Co.,ltd
Shenzhen Med-Link Electronics Tech Co.,ltd: FDA-registered device maker in Shenzhen Guangdong, China, 14 510(k) clearances
Shenzhen Med-Link Electronics Tech Co.,ltd is registered with the FDA (registration 3006636961) in Shenzhen Guangdong, China. It lists 18 device types. The FDA files 14 510(k) clearances under its listings, the newest dated January 8, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006636961
- 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, China, 518109
- Owner or operator
- Shenzhen Med-Link Electronics Tech Co.,Ltd (10030237)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 1, 2009
- Registered through
- 2027
- Brand names listed
- Disposable Gas Sampling Line, Disposable Non-invasive EEG Sensor, Disposable Pressure Infusion Bag, Electrosurgical Reusable Cables, Goggles, HUMIDIFIER, RESPIRATORY GAS, Hylink, Incontinence probe and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 8, 2026 | K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | FLL | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| January 19, 2023 | K220448 | Disposable Non-invasive EEG Sensor | GXY | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| June 28, 2022 | K220447 | Med-link Disposable ECG Cable and Leadwires | DSA | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| May 20, 2022 | K212752 | Med-link Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| September 17, 2021 | K210441 | Incontinence Probe | KPI | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| March 1, 2021 | K202743 | Med-Link Temp-pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| August 25, 2020 | K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | FLL | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| August 2, 2019 | K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| June 18, 2019 | K182667 | Med-link Temperature Probes | FLL | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| August 2, 2018 | K173869 | Med-link Reusable Blood Pressure Cuff | DXQ | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| November 28, 2016 | K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff | DXQ | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| March 21, 2013 | K113727 | SHENZHEN MED-LINK PULSE OXIMETER PROBE | DQA | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| January 19, 2012 | K120010 | CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) | DSA | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
| June 10, 2009 | K083010 | SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR | DQA | Substantially Equivalent | Shenzhen Med-Link Electronics Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Continuous Measurement Thermometer
- All makers of Perineometer
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Updated January 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.