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Omega-3 Test (v4)
EUDAMEDClass IIa (EU MDR)
Ref OMEG-01Model DBSRef OMEG-02
by LykonDX GmbH
Identity
- Trade Name
- Omega-3 Test (v4) EUDAMED
- Model / Reference
- DBS EUDAMEDOMEG-01 EUDAMEDOMEG-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640119173 EUDAMED04260640119166 EUDAMED
- Basic UDI-DI
- 4260640110000062X 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
Omega-3 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 | 4260640110000062X | Class IIa | Active |
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Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (2)
- EUDAMED 1415a235-c586-4178-ade5-92671fb46a02 61 fields · synced Jul 25, 2026
- EUDAMED 9e9840b7-2c9e-42d0-b0b7-856f9e308d8e 61 fields · synced May 19, 2026