limb clamp ecg electrodes
by Shenzhen Amydi-med Electrics Tech Co., Ltd 7 variants
Ref AMD-LE-AM0001-I, AMD-LE-AB0002-X, AMD-LE-AB0004-X, AMD-LE-AB0001-A, AMD-LE-AM0001-AModel AMD-SE/LE
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69313772807UW | Date28 Aug 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- ECG electrodes
- Model / Reference
- AMD-SE/LE, AMD-LE-AM0001-I, AMD-LE-AB0002-X, AMD-LE-AB0004-X, AMD-LE-AB0001-A, AMD-LE-AM0001-A
- Primary DI / UDI-DI
- 06931377230971, 06931377230933, 06931377230902, 06931377231015, 06931377231039
- Basic UDI-DI
- 69313772807UW
- EMDN Code
- Z1203020285 Multi-parameter monitors - consumables
- 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 (12)
- Sterile: No
- Implantable: 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