ECG /EKG Cable and Leadwire
by Shenzhen Minder Biomedical Tech Co., Ltd.
Ref EC10013SEModel EC10013SE,EC10083SE,EC3001013SE,EK1001BE,EC10013SA, EC10083FE,EC3001013SA,EK1001BA,EC10013FE,EC10086SE, EC3001013FE,EK1001CE, EC10013FA,EC10086FE,EC3001013FA, EK1001CA,EC10015SE,EC10093SE,EC3001025SE,EK1001SE, EC10015SA,EC10093FE,EC3001025SA,etc
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 | Number698018047ECLPH 06980180470005 | Date4 Jun 2026 | 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- Withdrawn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
- ECG /EKG Cable and Leadwire
- Model / Reference
- EC10013SE, EC10083SE, EC3001013SE, EK1001BE, EC10013SA, EC10083FE, EC3001013SA, EK1001BA, EC10013FE, EC10086SE, EC3001013FE, EK1001CE, EC10013FA, EC10086FE, EC3001013FA, EK1001CA, EC10015SE, EC10093SE, EC3001025SE, EK1001SE, EC10015SA, EC10093FE, EC3001025SA, etc
- Primary DI / UDI-DI
- 06980180470005
- Basic UDI-DI
- 698018047ECLPH
- EMDN Code
- C020599 Cardiac diagnostic devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000008776
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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