Electrode pad/gel
by Shenzhen Qishun Technology Co., Ltd. EUDAMED
Active
Ref 70101Model 70101,70102,70103,70104,70105,70106,70107,70108,70109, 70110, BWX2200 BWX3200, BWX4000, BWX5000, BWX7000, BWX4040, BWX5050,BWX4060,BWX4080,BWX4090,BWX5090, BWX50100, BWX70120, BWX75130, BWX901500, BWX1001500, etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697911047EPG001FR | Date17 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Electrode pad/gel
- Model / Reference
- 70101, 70102, 70103, 70104, 70105, 70106, 70107, 70108, 70109, 70110, BWX2200 BWX3200, BWX4000, BWX5000, BWX7000, BWX4040, BWX5050, BWX4060, BWX4080, BWX4090, BWX5090, BWX50100, BWX70120, BWX75130, BWX901500, BWX1001500, etc
- Primary DI / UDI-DI
- 06979110470208
- Basic UDI-DI
- 697911047EPG001FR
- EMDN Code
- K0201010301 Open electrosurgery electrodes, single-use
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000049367
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Qishun Technology Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No