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Eldonbox 2511-100
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 400-02Model 400-02v09Ref 400-00Model 400-00v09Ref 400-01Model 400-01v11
Identity
- Trade Name
- ELDONBOX 2511-100 EUDAMED
- Device Name
- ELDONBOX 2511-100 EUDAMED
- Model / Reference
- 400-02v09 EUDAMED400-02 EUDAMED400-00v09 EUDAMED400-00 EUDAMED400-01v11 EUDAMED400-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713494001860 EUDAMED05713494002485 EUDAMED05713494002393 EUDAMED
- Basic UDI-DI
- B-05713494001860 EUDAMEDB-05713494002485 EUDAMEDB-05713494002393 EUDAMED
- EMDN Code
- W0103030999 COMBINED ABO TYPING + RHESUS TYPING TEST - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDGermany EUDAMEDDenmark 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 2511-100 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-05713494001860 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- Eldon Biologicals A/S
- EUDAMED SRN
- DK-MF-000025470
Sources (3)
- EUDAMED 4424fe12-1c0b-419f-8f5d-fb89c2672317 61 fields · synced Jul 23, 2026
- EUDAMED c9ab87fa-b4e9-4a39-b3be-c2a6cedcb5cc 61 fields · synced May 19, 2026
- EUDAMED 600a2adc-7fac-4f7f-b693-3a9c0c4d19dd 61 fields · synced May 19, 2026