Identity
- Trade Name
- FARADRIVE™ EUDAMED
- Device Name
- FARADRIVE Steerable Sheath (clear) EUDAMED
- Model / Reference
- 21M402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810087180072 EUDAMED
- Basic UDI-DI
- B-00810087180072 EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular catheter introduction set, nonimplantable
Faradrive™ by Farapulse Inc — Class III — MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810087180072 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Farapulse Inc
- EUDAMED SRN
- US-MF-000017969
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 07932659-c664-4c83-aa27-f37de44fa92a 61 fields · synced Jun 18, 2026