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Women's Health Test (v1)
EUDAMEDClass IIa (EU MDR)
Ref ADX-WOHE-02Model DBS-ADXRef ADX-WOHE-01
by LykonDX GmbH
Identity
- Trade Name
- Women's Health Test (v1) EUDAMED
- Model / Reference
- DBS-ADX EUDAMEDADX-WOHE-02 EUDAMEDADX-WOHE-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640118381 EUDAMED04260640118398 EUDAMED
- Basic UDI-DI
- 4260640110000102N EUDAMED
- EMDN Code
- W0501010201 CAPILLARY BLOOD COLLECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Entnahme und primäre Aufbewahrung einer Kapillarblutprobe durch Laienanwender in der häuslichen Umgebung. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Women's Health Test (v1) 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 | 4260640110000102N | Class IIa | Active |
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Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (2)
- EUDAMED 6c694faa-212e-4e23-8613-e6810fa9261b 61 fields · synced Jul 20, 2026
- EUDAMED e62bf75c-d85d-4636-98e6-6cc63482f713 61 fields · synced May 19, 2026