← Back to catalogue
Health&Fitness Premium Test (v3)
EUDAMEDClass IIa (EU MDR)
Ref HF-PR-02Model BT-SG-DBSRef HF-PR-01
by LykonDX GmbH
Identity
- Trade Name
- Health&Fitness Premium Test (v3) EUDAMED
- Model / Reference
- BT-SG-DBS EUDAMEDHF-PR-02 EUDAMEDHF-PR-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260640119548 EUDAMED04260640119555 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 (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 | 4260640110000052V | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LykonDX GmbH
- EUDAMED SRN
- DE-PR-000005929
Sources (2)
- EUDAMED 70f5407c-e06e-405d-b347-97139a0414d9 61 fields · synced Jun 20, 2026
- EUDAMED 4eddea66-180d-4f4d-8ac2-0ee01595f31c 61 fields · synced May 17, 2026