Identity
- Device Name
- Leucosep tubes EUDAMED
- Model / Reference
- LTK.615 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051716000032 EUDAMED
- Basic UDI-DI
- 5051716LTKCA EUDAMED
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Leucosep tubes 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 | 5051716LTKCA | 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 d1b566bb-316f-49bf-93ce-9987eb91e844 61 fields · synced Jul 26, 2026