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Food Allergies Test (v4)
EUDAMEDClass IIa (EU MDR)
Ref ALLE-01Model BT-LH
by LykonDX GmbH
Identity
- Trade Name
- Food Allergies Test (v4) EUDAMED
- Model / Reference
- BT-LH EUDAMEDALLE-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640118916 EUDAMED
- Basic UDI-DI
- 4260640110000012M EUDAMED
- EMDN Code
- W0501010201 CAPILLARY BLOOD COLLECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Collection and primary preservation of a capillary blood sample by laypersons in a home environment. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Food Allergies Test (v4) by LykonDX GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4260640110000012M | Class IIa | Active |
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Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (1)
- EUDAMED 6ddedf2b-cc95-4059-beb2-f703298e4389 61 fields · synced Jun 18, 2026