Identity
- Trade Name
- REDI-Dx EUDAMED
- Device Name
- Radiation Biodosimetry Test (REDI-Dx Test System) EUDAMED
- Model / Reference
- 135488 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850521006032 EUDAMED
- Basic UDI-DI
- B-00850521006032 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
REDI-Dx by DxTerity Diagnostics Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00850521006032 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DxTerity Diagnostics Inc.
- EUDAMED SRN
- US-MF-000029372
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 99cfb3da-000a-4810-8f33-4a1edeb62200 61 fields · synced Jul 14, 2026