Identity
- Trade Name
- EurobioPlex DermaXtract EUDAMED
- Device Name
- EurobioPlex DermaXtract EUDAMED
- Model / Reference
- EBE-077-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03366160501236 EUDAMED
- Basic UDI-DI
- 033661605EBE077PP EUDAMED
- Direct Marketing DI
- 03366160501236 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Category: Nucleic acid extraction/isolation kit IVD
EurobioPlex DermaXtract by Eurobio Scientific — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 033661605EBE077PP | Class A | Active |
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Manufacturer
- Manufacturer
- Eurobio Scientific
- EUDAMED SRN
- FR-MF-000011745
Sources (1)
- EUDAMED c51b0096-9fff-4786-a6eb-2bca8609e05b 61 fields · synced Jun 18, 2026