Data / Medical devices / China / Shenzhen Medke Technology Co., Ltd.
Shenzhen Medke Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Shenzhen Medke Technology Co., Ltd. is registered with the FDA (registration 3012804266) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 20, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012804266
- Address
- 401, 503, Bldg. A1, Anle Ind. Zone, No.172, Hangcheng RD, Sanwei Community, Hangcheng Street, Baoan District, Shenzhen Guangdong, China, 518126
- Owner or operator
- Shenzhen Medke Technology Co., Ltd. (10053289)
- Roles
- Manufacturer
- First device listed
- November 16, 2016
- Registered through
- 2027
- Brand names listed
- ECG Cables (model: G312AMD-B, G512DT, G311NK, G5143DT), ECG Cables (model: G511AA-MB, G511SL-M, G512PH-M, G511DR-6P, G511PH-M, G512DN, G511PH-M, G511MD-M, G511AA, G512DT), Medke Disposable Temperature Probe, T5106, T6106, Medke Reusable Temperature Probe, T1306, T2306, T3306, T4306, Medke SpO2 Sensor, P9115S, P9318E, P9318H, P9325A, P9310F, P9119A, P8119A, P8115F, P8325A, P8310F, Medke Spo2 sensor, P8119, P9119, P8325A, P8310F, NIBP CUFFS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| June 20, 2025 | K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | FLL | Substantially Equivalent | Shenzhen Medke Technology Co., Ltd. | accessdata.fda.gov |
| October 31, 2024 | K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | DXQ | Substantially Equivalent | Shenzhen Medke Technology Co., Ltd. | accessdata.fda.gov |
| August 18, 2016 | K152390 | Medke Oximetry Finger Sensor | DQA | Substantially Equivalent | Shenzhen Medke Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Blood Pressure Cuff
- All makers of Continuous Measurement Thermometer
- All makers of Oximeter
- All makers of Cable, Electrode
Updated June 20, 2025. 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.