Identity
- Trade Name
- T-SPOT.COVID EUDAMED
- Device Name
- T-SPOT.COVID EUDAMED
- Model / Reference
- COV.435/300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051716000193 EUDAMED
- Basic UDI-DI
- B-05051716000193 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.covid 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-05051716000193 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Oxford Immunotec Ltd
- EUDAMED SRN
- GB-MF-000004429
- Authorised Representative
- Oxford Immunotec (Ireland) Ltd IE-AR-000003507
Sources (1)
- EUDAMED 3fb366c3-add6-42e6-864a-bd89c96bdc87 61 fields · synced Aug 2, 2026