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ELDONBOX RhD-100
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 460-00Model 460-00v02
Identity
- Trade Name
- ELDONBOX RhD-100 EUDAMED
- Device Name
- ELDONBOX RhD-100 EUDAMED
- Model / Reference
- 460-00v02 EUDAMED460-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713494002096 EUDAMED
- Basic UDI-DI
- B-05713494002096 EUDAMED
- EMDN Code
- W0103030299 RHESUS TYPING ASSAYS OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ELDONBOX RhD-100 by Eldon Biologicals A/S — Class IVD Annex II List A — 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-05713494002096 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- Eldon Biologicals A/S
- EUDAMED SRN
- DK-MF-000025470
Sources (1)
- EUDAMED f3941e05-b49c-4b0f-b1ca-717d267d15ac 61 fields · synced Jun 19, 2026