ECG Electrode
by Shenzhen Ykd Technology Co., Ltd.
Ref CKC001C2Model CKC001A1、 CKC001A2、 CKC001B1、 CKC001B2、 CKC001C1、 CKC001C2、CKC011B、CKC013E、CKC012、CKC012B、CKC014C、CKC011、CKC005、CKC005B、CKC009、CKC011D、CKC007、CKC013B
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 | Number697531983EE01KV 06975319839068 | Date22 Apr 2024 | 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- Withdrawn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 electrodes
- Model / Reference
- CKC001A1、 CKC001A2、 CKC001B1、 CKC001B2、 CKC001C1、 CKC001C2、CKC011B、CKC013E、CKC012、CKC012B、CKC014C、CKC011、CKC005、CKC005B、CKC009、CKC011D、CKC007、CKC013B, CKC001C2
- Primary DI / UDI-DI
- 06975319839068
- Basic UDI-DI
- 697531983EE01KV
- EMDN Code
- C020501 ECG electrodes
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000017263
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shenzhen Ykd 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