Identity
- Device Name
- ZENIX DEFIBRILLATION ACCESSORIES EUDAMED
- Model / Reference
- 8300-0804-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847946056216 EUDAMED
- Basic UDI-DI
- 08479460BBBG 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
Category: Electrocardiographic electrode, single-use
Zenix Defibrillation Accessories by Zoll Medical Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 08479460BBBG | 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 b5aca574-8074-4ab0-b7a4-e2d73f46e4a2 61 fields · synced Jul 14, 2026