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DNA Slim Test (v5)
EUDAMEDClass I (EU MDR)
Ref DNA-SL-06-FGPModel SW-BUCRef DNA-SL-03-FGPRef DNA-SL-05Ref DNA-SL-03
by LykonDX GmbH
Identity
- Trade Name
- DNA Slim Test (v5) EUDAMED
- Model / Reference
- SW-BUC EUDAMEDDNA-SL-06-FGP EUDAMEDDNA-SL-03-FGP EUDAMEDDNA-SL-05 EUDAMEDDNA-SL-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640118602 EUDAMED04260640118619 EUDAMED04260640118558 EUDAMED04260640118589 EUDAMED
- Basic UDI-DI
- 4260640110000112Q EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Entnahme und primäre Aufbewahrung einer Zellprobe aus der Wangenschleimhaut durch Laienanwender in der häuslichen Umgebung. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: General-purpose absorbent tip applicator/swab, single-use
DNA Slim Test (v5) by LykonDX GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 4260640110000112Q | Class I | Active |
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Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (4)
- EUDAMED c90a3147-5bc9-46be-8b4f-f2e37931a0e5 61 fields · synced Jul 16, 2026
- EUDAMED bb0b06b4-3c41-4ddd-823a-6faa55db7389 61 fields · synced May 18, 2026
- EUDAMED 172c5d5b-bb28-4ea7-9c57-1a024cb169e8 61 fields · synced May 18, 2026
- EUDAMED 6e058f41-7d07-484d-a1a2-1625a1e4fb0c 61 fields · synced May 19, 2026