Identity
- Trade Name
- ECG Cables EUDAMED
- Device Name
- ECG Lead wires EUDAMED
- Model / Reference
- A3009-EK1A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946725532423 EUDAMED
- Basic UDI-DI
- 69467255A-ECG-cableA6 EUDAMED
- EMDN Code
- Z12030285 VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ECG Cables by APK Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69467255A-ECG-cableA6 | Class I | Active |
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Manufacturer
- Manufacturer
- APK Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000011581
- Authorised Representative
- Ruiyi Healthcare GmbH DE-AR-000005962
Sources (1)
- EUDAMED b2ac9e24-7e8e-4d04-9704-09225289b4f1 61 fields · synced Aug 1, 2026