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Sign in to claim this brandSHENZHEN MEDKE TECHNOLOGY CO., LTD.
China·CN-MF-000019638
Last updated September 17, 2026
Information
- Country
- China
- Address
- 401, 503, Bldg. A1, Anle Ind. Zone No. 172, Hangcheng RD., Sanwei Community, Hangcheng Street Baoan District 518126 Shenzhen PEOPLE'S REPUBLIC OF CHINA, Shenzhen, China
- Website
- medke.com
- —
- —
- [email protected]
- Phone
- +86-755-23563462
- PRRC Contact
- Hui Lu
- EUDAMED SRN
- CN-MF-000019638
- FDA FEI Number
- 3012804266
- DUNS Number
- —
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spo2 sensors | (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) | EUDAMED | Class IIb | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMEDFDA UDI | Class I | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Spo2 sensors | (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) | EUDAMEDFDA UDI | Class IIb | Active |
| Spo2 sensors | (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) | EUDAMED | Class IIb | Active |
| Spo2 sensors | (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) | EUDAMEDFDA UDI | Class IIb | Active |
| Spo2 sensors | Directive 93/42/EEC on Medical Devices (MDD), Annex Il excluding (4)(Devices in Class Ila, Ilb or Ill) | EUDAMEDFDA UDI | Class IIb | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Spo2 sensors | (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) | EUDAMEDFDA UDI | Class IIb | Active |
| Spo2 sensors | (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) | EUDAMEDFDA UDI | Class IIb | Active |
| Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | K242623 | FDA 510(k) | Class II | Active |
| Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | K243000 | FDA 510(k) | Class II | Active |
| Medke Oximetry Finger Sensor | K152390 | FDA 510(k) | Class II | Active |
| ECG/EKG cable | Classification Rule Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Spo2 sensors | G1 085432 0004 Rev.00 | EUDAMEDFDA UDI | Class IIb | Active |
| Spo2 sensors | (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) | EUDAMED | Class IIb | Active |
| Spo2 sensors | (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) | EUDAMEDFDA UDI | Class IIb | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Spo2 sensors | Directive 93/42/EEC on Medical Devices (MDD), Annex Il excluding (4)(Devices in Class Ila, Ilb or Ill) | EUDAMEDFDA UDI | Class IIb | Active |
| Spo2 sensors | (Devices in Class lla, Ilb or Ill) Directive 93/42/EEC on Medical Devices (MDD),Annex ll excluding (4) | EUDAMED | Class IIb | Active |
| Nibp Cuff | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Spo2 sensors | Directive 93/42/EEC on Medical Devices (MDD), Annex Il excluding (4)(Devices in Class Ila, Ilb or Ill) | EUDAMEDFDA UDI | Class IIb | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| SpO2 sensor adapter cables | Annexes II and III of the Regulation (EU) 2017/745 Rule 1 | EUDAMED | Class I | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Spo2 sensors | Directive 93/42/EEC on Medical Devices (MDD), Annex Il excluding (4)(Devices in Class Ila, Ilb or Ill) | EUDAMED | Class IIb | Active |
| Patient cables and Lead wires | Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 | EUDAMED | Class I | Active |
| Spo2 sensors | Directive 93/42/EEC on Medical Devices (MDD), Annex Il excluding (4)(Devices in Class Ila, Ilb or Ill) | EUDAMED | Class IIb | Active |
| Spo2 sensors | Directive 93/42/EEC on Medical Devices (MDD), Annex Il excluding (4)(Devices in Class Ila, Ilb or Ill) | EUDAMEDFDA UDI | Class IIb | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Shenzhen MedKe Technology Co., Ltd US