Identity
- Trade Name
- ImmuView EUDAMED
- Device Name
- ImmuView L. pneumophila and L. Longbeachae Urinary Antigen Test EUDAMED
- Model / Reference
- 98749 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ImmuView_Lut_LutLW EUDAMED
- Basic UDI-DI
- B-ImmuView_Lut_LutLW EUDAMED
- EMDN Code
- W01021699 RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Denmark 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
ImmuView by SSI Diagnostica A/S — Class IVD General — 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-ImmuView_Lut_LutLW | Class IVD General | Active |
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Manufacturer
- Manufacturer
- SSI Diagnostica A/S
- EUDAMED SRN
- DK-MF-000023933
Sources (1)
- EUDAMED c88fb21d-afdd-4a4c-9fd4-7301dd1b9abf 61 fields · synced Jun 9, 2026