Shenzhen Medke Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 4 device types, 2 products catalogued, 3 clearances.
Shenzhen Medke Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Cable, Electrode and 2 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
4device types registered with the FDA
2products catalogued under its own name
3510(k) clearances
Registration
| Registered name | SHENZHEN MEDKE TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012804266 |
| FEI number | 3012804266 |
| DUNS | 529655709 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市曼克科技有限公司 |
|---|---|
| Unified social credit code | 91440300683788713H |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 401, 503, Bldg. A1, Anle Ind. Zone, No.172, Hangcheng RD, Sanwei Community, Hangcheng Street, Baoan District |
| Postal code | 518126 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Nibp Cuffs | 2024 | 50 |
| Cable, Electrode | Class 2 | ECG Cables (model: G511AA-MB, G511SL-M, G512PH-M, G511DR-6P, G511PH-M, G512DN, G511PH-M, G511MD-M, G511AA, G512DT), ECG Cables (model: G312AMD-B, G512DT, G311NK, G5143DT) | 2019 | 47 |
| Continuous Measurement Thermometer | Class 2 | Medke Reusable Temperature Probe, T1306, T2306, T3306, T4306, Medke Disposable Temperature Probe, T5106, T6106 | 2025 | 115 |
| Oximeter | Class 2 | Medke Spo2 sensor, P8119, P9119, P8325A, P8310F, Medke SpO2 Sensor, P9115S, P9318E, P9318H, P9325A, P9310F, P9119A, P8119A, P8115F, P8325A, P8310F | 2016 | 70 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243000 | 2025-06-20 | FLL | Traditional | This company |
| K242623 | 2024-10-31 | DXQ | Traditional | This company |
| K152390 | 2016-08-18 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Factory area | 4000+ 平方米 |
| Main products | SpO2 sensors, ECG cables, Temperature probes, NIBP cuffs, EEG cables |
| Certifications | FDA, ISO 13485, TÜV CE, EU MDR |
| Export markets | 100+ 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.
The manufacturer named here can complete this record.