Identity
- Trade Name
- Packs for Biocare EUDAMED
- Device Name
- ECG Electrodes EUDAMED
- Model / Reference
- 20.112.19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033040541365 EUDAMED
- Basic UDI-DI
- 803304054EFELEECGBR EUDAMED
- EMDN Code
- Z1302 DIAGNOSTIC REGISTRATION PAPERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Packs for Biocare by EF Medica Srl — 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 | 803304054EFELEECGBR | Class I | Active |
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Manufacturer
- Manufacturer
- EF Medica Srl
- EUDAMED SRN
- IT-MF-000009938
Sources (1)
- EUDAMED d94423dc-61eb-46f2-ae0a-8d3d4b08b0cd 61 fields · synced Jun 17, 2026