Identity
- Trade Name
- FRACTIOsmart™Large 2.0 EUDAMED
- Device Name
- PLASMA FRACTIONATORS EUDAMED
- Model / Reference
- M90101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033772327985 EUDAMED
- Basic UDI-DI
- 803377232FRAHZ EUDAMED
- EMDN Code
- B030203 SINGLE PLASMA COMPONENTS REMOVAL DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FRACTIOsmart™Large 2.0 by Medica S.p.A. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803377232FRAHZ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medica S.p.A.
- EUDAMED SRN
- IT-MF-000025691
Sources (1)
- EUDAMED 76cbb5c2-1c2a-4ea8-8870-e3b2dbad0a72 61 fields · synced Jul 22, 2026