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COVID-19 ANTIKÖRPER (v2)
EUDAMEDClass IIa (EU MDR)
Ref COV-19-01Model BT-SE
by LykonDX GmbH
Identity
- Trade Name
- COVID-19 ANTIKÖRPER (v2) EUDAMED
- Model / Reference
- BT-SE EUDAMEDCOV-19-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640119999 EUDAMED
- Basic UDI-DI
- 4260640110000032R EUDAMED
- EMDN Code
- W0501010201 CAPILLARY BLOOD COLLECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Diese Behandlungseinheit dient der Entnahme einer Kapillarblutprobe durch Laienanwender in der häuslichen Umgebung, der primären Aufbewahrung, Erhaltung sowie dem Probenversand zu einem akkreditierten Labor. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
COVID-19 ANTIKÖRPER (v2) 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 | 4260640110000032R | Class IIa | Active |
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Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (1)
- EUDAMED 76cef0b7-541e-4e92-9b1f-2dae92593324 61 fields · synced Jun 19, 2026