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Food Reaction Test (v5)
EUDAMEDClass IIa (EU MDR)
Ref NUTR-03Model BT-LHRef NUTR-01Ref NUTR-02
by LykonDX GmbH
Identity
- Trade Name
- Food Reaction Test (v5) EUDAMED
- Model / Reference
- BT-LH EUDAMEDNUTR-03 EUDAMEDNUTR-01 EUDAMEDNUTR-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640118831 EUDAMED04260640118848 EUDAMED04260640118824 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 Reaction Test (v5) 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 (3)
- EUDAMED 2cff84cc-6eea-4ad5-a87f-10aebe2f6a85 61 fields · synced Jul 12, 2026
- EUDAMED 68bbe878-d68e-4b62-9be7-fa5d8f6d4e6c 61 fields · synced May 18, 2026
- EUDAMED 83684ace-8f32-400a-afad-b3ca2cda3b80 61 fields · synced May 18, 2026