← Back to catalogue
F47709vk
EUDAMEDClass IIa (EU MDR)
Ref F47709VKModel Hemostasis valve percutaneous introduction set
by FIAB S.p.A.
Identity
- Model / Reference
- Hemostasis valve percutaneous introduction set EUDAMEDF47709VK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054242444025 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
F47709vk by FIAB S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter introduction set, nonimplantable.
- VYGON — Vygon Corp. · Class II
- OneStic Micro-Access Introducer — Argon Medical Devices, Inc. · Class II
- Prelude EASE™ — Merit Medical Systems, Inc. · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED d386fc7b-5903-4ebc-be6b-25a943ab2e19 61 fields · synced Jul 14, 2026