Shenzhen Med-Link Electronics Tech Co.,Ltd
Shenzhen Guangdong, CN
SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Shenzhen Med-Link Electronics Tech Co.,Ltd between 2009 and 2026. The busiest year on record is 2019, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | FLL | Substantially Equivalent | |
| K220448 | Disposable Non-invasive EEG Sensor | GXY | Substantially Equivalent | |
| K220447 | Med-link Disposable ECG Cable and Leadwires | DSA | Substantially Equivalent | |
| K212752 | Med-link Pulse Oximeter | DQA | Substantially Equivalent | |
| K210441 | Incontinence Probe | KPI | Substantially Equivalent | |
| K202743 | Med-Link Temp-pulse Oximeter | DQA | Substantially Equivalent | |
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | FLL | Substantially Equivalent | |
| K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K182667 | Med-link Temperature Probes | FLL | Substantially Equivalent | |
| K173869 | Med-link Reusable Blood Pressure Cuff | DXQ | Substantially Equivalent | |
| K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff | DXQ | Substantially Equivalent | |
| K113727 | SHENZHEN MED-LINK PULSE OXIMETER PROBE | DQA | Substantially Equivalent | |
| K120010 | CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE) | DSA | Substantially Equivalent | |
| K083010 | SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR | DQA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006636961 | 3006636961 | SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD | Zone A of first and second Floor, and third Floor, Building A, No. seven, Tongsheng Industrial Park Road, Shenzhen Guangdong 518109 CN | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DXQBlood Pressure Cuff
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- CATCannula, Nasal, Oxygen
- FLLContinuous Measurement Thermometer
- BYHDrain, Tee (Water Trap)
- FYEDress, Surgical
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- KZDInfusor, Pressure, For I.V. Bags
- DQAOximeter
- HIRPerineometer
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- JFCSystem, Pressure Measurement, Intermittent
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain