Identity
- Trade Name
- Swelab Alfa Plus Sampler BD AR EUDAMED
- Device Name
- Swelab Alfa Plus EUDAMED
- Model / Reference
- 1420046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350040791226 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 Sampler BD AR 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boule Medical AB
- EUDAMED SRN
- SE-MF-000001911
Sources (1)
- EUDAMED 29cc0f99-67bc-466b-9abc-5fc159c356f3 61 fields · synced Jul 17, 2026