Identity
- Trade Name
- ImmuView® Reader 2.0 EUDAMED
- Device Name
- ImmuView® Reader 2.0 EUDAMED
- Model / Reference
- 213414 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713106000076 EUDAMED
- Basic UDI-DI
- 5713106ImmuView_Read23J8 EUDAMED
- Direct Marketing DI
- 05713106000076 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
ImmuView® Reader 2.0 by SSI Diagnostica A/S — Class A — 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 | 5713106ImmuView_Read23J8 | Class A | Active |
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Manufacturer
- Manufacturer
- SSI Diagnostica A/S
- EUDAMED SRN
- DK-MF-000023933
Sources (1)
- EUDAMED c5ee9b0a-93a2-448a-8f7c-722f50ff0e35 61 fields · synced Jun 19, 2026