← Back to catalogue
ImmuView S. pneumoniae og L. pneumophila Urinary Antigen Test
EUDAMEDClass IVD General (EU MDR)
Ref 95389Ref 98748
Identity
- Trade Name
- ImmuView EUDAMED
- Device Name
- ImmuView S. pneumoniae og L. pneumophila Urinary Antigen Test EUDAMEDImmuView S. pneumoniae Antigen Test EUDAMED
- Model / Reference
- 95389 EUDAMED98748 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ImmuView_Put_LutP2 EUDAMEDD-ImmuView_PutMK EUDAMED
- Basic UDI-DI
- B-ImmuView_Put_LutP2 EUDAMEDB-ImmuView_PutMK 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 S. pneumoniae og L. pneumophila Urinary Antigen Test by SSI Diagnostica A/S — Class IVD General — IVDD — listed in EUDAMED
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_Put_LutP2 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SSI Diagnostica A/S
- EUDAMED SRN
- DK-MF-000023933
Sources (2)
- EUDAMED e142a85a-0e8d-4849-937a-32fb23c1363f 61 fields · synced Jul 24, 2026
- EUDAMED 4c42a250-ab04-4881-80cf-d6f1fcf8d1df 61 fields · synced Jul 9, 2026