Identity
- Trade Name
- T-SPOT.CMV EUDAMED
- Device Name
- T-SPOT.CMV EUDAMED
- Model / Reference
- CMV.400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051716000407 EUDAMED
- Basic UDI-DI
- B-05051716000407 EUDAMED
- EMDN Code
- W0105900299 INFECTIOUS IMMUNOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
T-Spot.cmv by Oxford Immunotec Ltd — 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-05051716000407 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Oxford Immunotec Ltd
- EUDAMED SRN
- GB-MF-000004429
- Authorised Representative
- Wallac Oy FI-AR-000044744
Sources (1)
- EUDAMED b0ce113b-373e-49b4-861e-ed9f9f3c41ad 61 fields · synced Jul 18, 2026