Shenzhen MED-Link Electronics Tech Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 18 device types, 12 products catalogued, 14 clearances.
Shenzhen MED-Link Electronics Tech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Perineometer and 16 other device types. 12 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
18device types registered with the FDA
12products catalogued under its own name
14510(k) clearances
Registration
| Registered name | SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006636961 |
| FEI number | 3006636961 |
| DUNS | 527221129 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市美连医疗电子股份有限公司 |
|---|---|
| Unified social credit code | 91440300758612510W |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Zone A of first and second Floor, and third Floor, Building A, No. seven, Tongsheng Industrial Park Road |
| Postal code | 518109 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Med-link Reusable Blood Pressure Cuff, Hylink, Med-linket | 2016 | 50 |
| Cable, Electrode | Class 2 | Med-link Temperature Probe Adapter Cable | 2021 | 47 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | Med-link Disposable ECG Cable and Leadwires, Med-Linket | 2012 | 22 |
| Cannula, Nasal, Oxygen | Class 1 | Disposable Gas Sampling Line | 2026 | 97 |
| Continuous Measurement Thermometer | Class 2 | Sterile Temperature Probe, Sterile temperature probe-W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0001QS, W0001FS, W0001PS, W0001LS, Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes, Med-link Temperature Probes, Med-link Pulse Oximeter | 2019 | 115 |
| Drain, Tee (Water Trap) | Class 1 | Water Trap | 2021 | 12 |
| Dress, Surgical | Class 1 | Protective Face Shield | 2020 | 71 |
| Electrode, Cutaneous | Class 2 | Disposable Non-invasive EEG Sensor | 2023 | 47 |
| Electrode, Electrocardiograph | Class 2 | Reusable and Disposable ECG Electrodes, Radiotransparent Leadwires | 2015 | 33 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Electrosurgical Reusable Cables | 2026 | 65 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | Class 2 | Humidifier, Respiratory GAS | 2024 | 12 |
| Infusor, Pressure, For I.V. Bags | Class 1 | Disposable Pressure Infusion Bag, infusor, pressure, for i.v. bags | 2013 | 25 |
| Oximeter | Class 2 | Pulse Oximeter, MED-Linket, MED-LINKET Reusable Spo2 Sensor S0005B-S S0005C-S S0005D-S S0005P-S S0005E-S S0005F-S S0005G-S S0005I-S, MED-LINKET Reusable Spo2 Sensor S0005B-L S0005C-L S0005D-L S0005P-L S0005F-L S0005I-L, Pulse Oximeter Probe, Med-linket disposable Spo2 sensor and 3 more | 2009 | 70 |
| Perineometer | Class 2 | Incontinence probe | 2021 | 7 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Goggles | 2020 | 384 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | Class 2 | Incontinence probe | 2021 | 7 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Med-link Upper Arm Digital Blood Pressure Monitor, Med-link Wrist Digital Blood Pressure Monitor | 2020 | 98 |
| System, Pressure Measurement, Intermittent | Class 1 | Interconnect tube | 2024 | 7 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251160 | 2026-01-08 | FLL | Traditional | This company |
| K220448 | 2023-01-19 | GXY | Traditional | This company |
| K220447 | 2022-06-28 | DSA | Traditional | This company |
| K212752 | 2022-05-20 | DQA | Traditional | This company |
| K210441 | 2021-09-17 | KPI | Traditional | This company |
| K202743 | 2021-03-01 | DQA | Traditional | This company |
| K193338 | 2020-08-25 | FLL | Traditional | This company |
| K181154 | 2019-08-02 | DXN | Traditional | This company |
| K182667 | 2019-06-18 | FLL | Traditional | This company |
| K173869 | 2018-08-02 | DXQ | Traditional | This company |
| K160530 | 2016-11-28 | DXQ | Traditional | This company |
| K113727 | 2013-03-21 | DQA | Traditional | This company |
| K120010 | 2012-01-19 | DSA | Traditional | This company |
| K083010 | 2009-06-10 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 200-300 |
| Factory area | 7000 m² |
| Main products | SpO2 sensors, Temperature probes, ECG cables, NIBP cuffs, IBP cables |
| Certifications | ISO13485, CE, FDA, CFDA, 150+ product certifications |
| Export markets | 120+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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