Identity
- Trade Name
- Swelab AlfaLyse, 900 cycles EUDAMED
- Device Name
- Swelab Alfa reagents EUDAMED
- Model / Reference
- 1504125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350040790182 EUDAMED
- Basic UDI-DI
- 735004079A013YD EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Swelab AlfaLyse, 900 cycles by Boule Medical AB — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 735004079A013YD | Class A | Active |
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Manufacturer
- Manufacturer
- Boule Medical AB
- EUDAMED SRN
- SE-MF-000001911
Sources (1)
- EUDAMED 703ee2f1-1c4e-40b2-98c1-b37425e20015 61 fields · synced Jun 19, 2026