Identity
- Trade Name
- Medonic M-series M32 C AR EUDAMED
- Device Name
- Medonic M-series M32 EUDAMED
- Model / Reference
- 1420024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350040796184 EUDAMED
- Basic UDI-DI
- 735004079A001Y6 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
Medonic M-series M32 C AR by Boule Medical AB — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083420 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 735004079A001Y6 | Class B | Active |
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Manufacturer
- Manufacturer
- Boule Medical AB
- EUDAMED SRN
- SE-MF-000001911
Sources (2)
- EUDAMED 12cfab19-a851-44cd-8021-d61078c51e61 61 fields · synced Jul 12, 2026
- FDA 510(k) K083420 1 fields · synced May 18, 2026