Identity
- Trade Name
- Swelab Alfa Plus Basic EUDAMED
- Device Name
- Swelab Alfa Plus EUDAMED
- Model / Reference
- 1420041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350040791172 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
The Swelab Alfa Plus Basic medical device is a highly specialized instrument used in the field of endocrinology. It is designed for the measurement and analysis of hormone levels, particularly in the context of diabetes management. By providing accurate and reliable results, this device enables healthcare professionals to make informed decisions about patient care.
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 76c11ed3-d03e-44c9-9cd3-e348b1bd61bf 61 fields · synced Jul 31, 2026