Identity
- Trade Name
- EliA ASCA IgG Well EUDAMED
- Device Name
- EliA ASCA IgG EUDAMED
- Model / Reference
- 14-5635-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333066015705 EUDAMED
- Basic UDI-DI
- 7333066BUDI0117M4 EUDAMED
- EMDN Code
- W0102100801 SACCHAROMYCES CEREVISIAE ANTIBODIES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
EliA ASCA IgG Well by Phadia AB — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0117M4 | Class B | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (1)
- EUDAMED 31c30ee8-dd1f-4fee-86c1-0573b5d92be2 61 fields · synced Jul 8, 2026