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Health&Fitness Premium Test (v4)
EUDAMEDClass IIa (EU MDR)
Ref HF-PR-01Model BT-SG-DBSRef HF-PR-02
by LykonDX GmbH
Identity
- Trade Name
- Health&Fitness Premium Test (v4) EUDAMED
- Model / Reference
- BT-SG-DBS EUDAMEDHF-PR-01 EUDAMEDHF-PR-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640119159 EUDAMED04260640119142 EUDAMED
- Basic UDI-DI
- 4260640110000052V 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
Health&Fitness Premium Test (v4) 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 | 4260640110000052V | Class IIa | Active |
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Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (2)
- EUDAMED c0b187b0-5f10-4866-a6b6-75d131d3d0b0 61 fields · synced Aug 4, 2026
- EUDAMED 389e41d0-6e31-4633-a9a4-7a4da674a311 61 fields · synced May 19, 2026