Identity
- Trade Name
- T-Cell Select EUDAMED
- Device Name
- T-Cell Select EUDAMED
- Model / Reference
- TSK.910 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051716000117 EUDAMED
- Basic UDI-DI
- 5051716TSKDF EUDAMED
- Direct Marketing DI
- 05051716000117 EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- 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
No
EUDAMED
New Device
No
EUDAMED
T-Cell Select by Oxford Immunotec Ltd — 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 | 5051716TSKDF | Class A | 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 0e634dfc-7bb0-4408-adfe-d3f13bccd806 61 fields · synced Jun 19, 2026