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DNA Slim Test (v3)
EUDAMEDClass I (EU MDR)
Ref DNA-SL-05Model SW-BUCRef DNA-SL-06Ref DNA-SL-04Ref DNA-SL-03
by LykonDX GmbH
Identity
- Trade Name
- DNA Slim Test (v3) EUDAMED
- Model / Reference
- SW-BUC EUDAMEDDNA-SL-05 EUDAMEDDNA-SL-06 EUDAMEDDNA-SL-04 EUDAMEDDNA-SL-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640118886 EUDAMED04260640118862 EUDAMED04260640118855 EUDAMED04260640118879 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 (v3) 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 2a1184c6-b3e9-4253-9211-55adcdff8204 61 fields · synced Jul 24, 2026
- EUDAMED c45cc78a-91a4-46a7-a4a4-7d2407bc2a08 61 fields · synced May 17, 2026
- EUDAMED de747b98-5abc-411b-8036-1648b15416e1 61 fields · synced May 17, 2026
- EUDAMED c3530278-1f56-4661-a958-33dc69007a37 61 fields · synced May 18, 2026