ECG Disposable Lead wires
by APK Technology Co., Ltd. China EUDAMED
Ref A0004D05-016 EMDN Z12030285
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69467255A-DECG-cableZF | Date17 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable ECG Lead wires
- Model / Reference
- A0004D05-016
- Primary DI / UDI-DI
- 06946725530290
- Basic UDI-DI
- 69467255A-DECG-cableZF
- EMDN Code
- Z12030285 Vital signs monitoring instruments - consumables
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011581
- Authorised representative
- Ruiyi Healthcare GmbH DE-AR-000005962
Other devices from APK Technology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 06946725530290|69467255A-DECG-CABLEZF