Disposable ECG electrode
by Shenzhen Amydi-med Electrics Tech Co., Ltd 31 variants
Ref AMD-DA-OP0007-XModel AMD-DA
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 | Number69313772817UZ 06931377244909 | Date3 Jul 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- Withdrawn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
- Model / Reference
- AMD-DA, AMD-DA-OP0007-X
- Primary DI / UDI-DI
- 06931377244909
- Basic UDI-DI
- 69313772817UZ
- EMDN Code
- C020501 ECG electrodes
- Device Class
- Class I
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000013201
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
From the manufacturer
Manufacturer's product page: ECG Electrode
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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