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Metabolic DNA Test (v5)
EUDAMEDClass I (EU MDR)
Ref DNA-SL-07-LSModel SW-BUC
by LykonDX GmbH
Identity
- Trade Name
- Metabolic DNA Test (v5) EUDAMED
- Model / Reference
- SW-BUC EUDAMEDDNA-SL-07-LS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640118367 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
Metabolic DNA 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 (1)
- EUDAMED e8d43121-7619-4094-8112-0b094d4b7003 61 fields · synced Aug 1, 2026