Identity
- Device Name
- Zenix ECG Accessories EUDAMED
- Model / Reference
- 8016-000629-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847946033989 EUDAMED
- Basic UDI-DI
- 08479460BABE EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Zenix ECG Accessories by Zoll Medical Corporation — 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 | 08479460BABE | Class I | Active |
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Manufacturer
- Manufacturer
- ZOLL Medical Corporation
- EUDAMED SRN
- US-MF-000021386
- Authorised Representative
- ZOLL International Holding B.V. NL-AR-000012554
Sources (1)
- EUDAMED 9dd634f0-58bc-4e55-a968-3b8777aa77c1 61 fields · synced Jul 31, 2026