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RE-Test (v3)
EUDAMEDClass IIa (EU MDR)
Ref EXTR-01Model BT-SGRef EXTR-02
by LykonDX GmbH
Identity
- Trade Name
- RE-Test (v3) EUDAMED
- Model / Reference
- BT-SG EUDAMEDEXTR-01 EUDAMEDEXTR-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640119470 EUDAMED04260640119463 EUDAMED
- Basic UDI-DI
- 4260640110000042T 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
RE-Test (v3) 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 | 4260640110000042T | Class IIa | Active |
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Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (2)
- EUDAMED 94cbcb56-6e60-4622-b863-4a8f1a1e355e 61 fields · synced Jul 11, 2026
- EUDAMED 117a544f-be50-4252-8af1-18d192efd1b3 61 fields · synced May 17, 2026