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F47705v.35
EUDAMEDClass IIa (EU MDR)
Ref F47705V.35Model Hemostasis valve percutaneous introduction set
by FIAB S.p.A.
Identity
- Model / Reference
- Hemostasis valve percutaneous introduction set EUDAMEDF47705V.35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054242444735 EUDAMED
- Basic UDI-DI
- 803300326222000002MH EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Vascular catheter introduction set, nonimplantable
F47705v.35 by FIAB S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 803300326222000002MH | Class IIa | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED 5feb67df-7932-4715-9f5e-ec35258a064a 61 fields · synced Sep 18, 2026