Identity
- Trade Name
- SPINFLUXTM 15 PUR HF EUDAMED
- Device Name
- Dialyzers with KUF 18 -35 ml/h/mmHg EUDAMED
- Model / Reference
- SPINFLUXTM 15 PUR HF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033772327770 EUDAMED
- Basic UDI-DI
- 803377232DIA-602YA EUDAMED
- EMDN Code
- F01060203 DIALYSERS - UFC = 18 - 35 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
Spinfluxtm 15 Pur Hf 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-602YA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medica S.p.A.
- EUDAMED SRN
- IT-MF-000025691
Sources (1)
- EUDAMED 035855c1-c4a3-4fdf-8717-677a711b41bf 61 fields · synced Oct 7, 2026