Identity
- Trade Name
- Swelab Alfa Plus Standard EUDAMED
- Device Name
- Swelab Alfa Plus EUDAMED
- Model / Reference
- 7350040791189 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350040791189 EUDAMED
- Basic UDI-DI
- 735004079A002Y8 EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Swelab Alfa Plus Standard by Boule Medical AB — Class B — 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 | 735004079A002Y8 | Class B | Active |
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Manufacturer
- Manufacturer
- Boule Medical AB
- EUDAMED SRN
- SE-MF-000001911
Sources (1)
- EUDAMED 1c1d9985-333a-428a-b118-2eb32d064b09 61 fields · synced Jun 19, 2026