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EpiScreen Plus Reagent 3
EUDAMEDClass B (EU MDR)
Ref EPI_PLUS_3Model EPI_PLUS
by FertiPro
Identity
- Trade Name
- EpiScreen Plus Reagent 3 EUDAMED
- Device Name
- EpiScreen Plus EUDAMED
- Model / Reference
- EPI_PLUS EUDAMEDEPI_PLUS_3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05411967001644 EUDAMED
- Basic UDI-DI
- 5411967EPIP1VD EUDAMED
- Direct Marketing DI
- 05411967001644 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
EpiScreen Plus Reagent 3 by FertiPro — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5411967EPIP1VD | Class B | Active |
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Manufacturer
- Manufacturer
- FertiPro
- EUDAMED SRN
- BE-MF-000000313
Sources (1)
- EUDAMED d193e0dc-64c0-493f-ba11-803fc8c7d95f 61 fields · synced Jun 18, 2026