Identity
- Trade Name
- Packs for Primedic/Edan/Schiller EUDAMED
- Device Name
- ECG Electrodes EUDAMEDThermal recording chart paper EUDAMED
- Model / Reference
- 20.080.05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033040543949 EUDAMED
- Basic UDI-DI
- 803304054EFELEECGBR EUDAMED803304054EFCARREGC8 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Packs for Primedic/Edan/Schiller 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 (2)
- EUDAMED aceb8886-1333-42b7-8e28-776a39345b18 61 fields · synced Jul 27, 2026
- EUDAMED 037781dd-8e28-49ac-8cb0-51cf9d0209e5 61 fields · synced Jul 27, 2026