Identity
- Trade Name
- Digest-EUR EUDAMED
- Device Name
- Digest-EUR EUDAMED
- Model / Reference
- DD0DIG00-AI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03366160500260 EUDAMED
- Basic UDI-DI
- 3661605DD0DIG00B6 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
Digest-EUR 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 | 3661605DD0DIG00B6 | Class A | Active |
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Manufacturer
- Manufacturer
- Eurobio Scientific
- EUDAMED SRN
- FR-MF-000011745
Sources (1)
- EUDAMED 9379e5bf-fa78-4dc9-adcd-cfaff6f429f5 61 fields · synced Jul 17, 2026