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Omega-3 Test (v3)
EUDAMEDClass IIa (EU MDR)
Ref OMEG-02Model DBSRef OMEG-01
by LykonDX GmbH
Identity
- Trade Name
- Omega-3 Test (v3) EUDAMED
- Model / Reference
- DBS EUDAMEDOMEG-02 EUDAMEDOMEG-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640119562 EUDAMED04260640119579 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 (v3) 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 6fc75bc7-34c1-4be3-a8b4-8d5b8b5a9f83 61 fields · synced Jul 19, 2026
- EUDAMED 5a2eea33-c007-4749-9ca1-a02ae69af2c6 61 fields · synced May 17, 2026