Electrode pads
by Shenzhen Kangdal Technology Co., Ltd.
Ref KDL-GModel KDL-A, KDL-B, KDL-C, KDL-D, KDL-E, KDL-F, KDL-G, KDL-H, KDL-I, KDL-J, KDL-K
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697815812KDL001JX 06978158120014 | Date6 Jan 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Electrode pads
- Model / Reference
- KDL-A, KDL-B, KDL-C, KDL-D, KDL-E, KDL-F, KDL-G, KDL-H, KDL-I, KDL-J, KDL-K
- Primary DI / UDI-DI
- 06978158120014
- Basic UDI-DI
- 697815812KDL001JX
- EMDN Code
- K0201010301 Open electrosurgery electrodes, single-use
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000045815
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Kangdal 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