Identity
- Device Name
- ImmuView Reader version 1.0 EUDAMED
- Model / Reference
- 18344 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ImmuView_Reader_1SE EUDAMED
- Basic UDI-DI
- B-ImmuView_Reader_1SE EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Northern Ireland 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
ImmuView Reader version 1.0 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_Reader_1SE | Class IVD General | Active |
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Manufacturer
- Manufacturer
- SSI Diagnostica A/S
- EUDAMED SRN
- DK-MF-000023933
Sources (1)
- EUDAMED 9bf275f7-caee-43bf-9932-b440bd11e80b 61 fields · synced Jul 31, 2026