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Health & Vitality Test Plus (v1)
EUDAMEDClass IIa (EU MDR)
Ref ADX-HEVI-01-PLUSModel DBS-ADXRef ADX-HEVI-02-PLUS
by LykonDX GmbH
Identity
- Trade Name
- Health & Vitality Test Plus (v1) EUDAMED
- Model / Reference
- DBS-ADX EUDAMEDADX-HEVI-01-PLUS EUDAMEDADX-HEVI-02-PLUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640118428 EUDAMED04260640118411 EUDAMED
- Basic UDI-DI
- 4260640110000102N EUDAMED
- EMDN Code
- W0501010201 CAPILLARY BLOOD COLLECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Entnahme und primäre Aufbewahrung einer Kapillarblutprobe durch Laienanwender in der häuslichen Umgebung. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Health & Vitality Test Plus (v1) 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 | 4260640110000102N | Class IIa | Active |
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Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (2)
- EUDAMED abb99d0b-a712-4fdb-9927-de734e3d3352 61 fields · synced Jul 21, 2026
- EUDAMED 38f12a55-8fe4-4394-a003-db3e18548746 61 fields · synced May 18, 2026