ECG Adapter
by APK Technology Co., Ltd. EUDAMED
Active
Ref A-CO-197
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69467255A-ECG-cableA6 | Date17 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- ECG Lead wires
- Model / Reference
- A-CO-197
- Primary DI / UDI-DI
- 06946725568651
- Basic UDI-DI
- 69467255A-ECG-cableA6
- 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
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