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Wellion AMADEUS
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref S5800475, S5800476, S5800477
Identity
- Trade Name
- Wellion AMADEUS EUDAMED
- Device Name
- Wellion AMADEUS Control Solution EUDAMED
- Model / Reference
- S5800475, S5800476, S5800477 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487603C3SY3 EUDAMED
- Basic UDI-DI
- B-47136487603C3SY3 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Wellion AMADEUS by Apex Biotechnology Corp. — Class IVD Annex II List B — 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-47136487603C3SY3 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000019773
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 13a2101b-58e0-47c2-954c-2a0164d0ad64 61 fields · synced Jul 9, 2026
- EUDAMED 13a2101b-58e0-47c2-954c-2a0164d0ad64-1 61 fields · synced Jun 10, 2026