Identity
- Trade Name
- DOCTORS KIT DKS RhD-25 EUDAMED
- Device Name
- DOCTORS KIT DKS RhD-25 EUDAMED
- Model / Reference
- 660-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713494002010 EUDAMED
- Basic UDI-DI
- B-05713494002010 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
DOCTORS KIT DKS RhD-25 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-05713494002010 | 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 67b2828f-878b-4292-9ab6-2383f7ee8aef 61 fields · synced Jul 13, 2026