Identity
- Trade Name
- Smartflux HFP.06 PUREMA- PEDIATRIC EUDAMED
- Device Name
- Dialyzers with KUF < 18 ml/h/mmHg EUDAMED
- Model / Reference
- M03690 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033772323338 EUDAMED
- Basic UDI-DI
- 803377232DIA-601Y8 EUDAMED
- EMDN Code
- F01060103 DIALYSERS - UFC < 18 ml/h/mmHg, SYNTHETIC MEMBRANES 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
Smartflux HFP.06 PUREMA- PEDIATRIC 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 | 803377232DIA-601Y8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medica S.p.A.
- EUDAMED SRN
- IT-MF-000025691
Sources (1)
- EUDAMED 5060b071-2b98-46a0-97b6-0df10e897493 61 fields · synced Jul 21, 2026