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DNA Slim Test (v1)
EUDAMEDClass I (EU MDR)
Ref DNA-SL-03Model SW-BUCRef DNA-SL-04
by LykonDX GmbH
Identity
- Trade Name
- DNA Slim Test (v1) EUDAMED
- Model / Reference
- SW-BUC EUDAMEDDNA-SL-03 EUDAMEDDNA-SL-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640119616 EUDAMED04260640119609 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
DNA Slim Test (v1) by LykonDX GmbH — Class I — 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 | 4260640110000112Q | Class I | Active |
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Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (2)
- EUDAMED 88515adc-b2cd-42c3-9e40-226f24c818d0 61 fields · synced Jul 10, 2026
- EUDAMED 3b9556f7-92d5-4924-889e-95073f5462c9 61 fields · synced May 16, 2026