Faradrive™
Ref 21M402
Faradrive (21M402) is a medical device (EU MDD Class III; EMDN category cardiovascular introducer sheaths) made by Farapulse Inc, registered in EUDAMED on 22 May 2026 (Basic UDI-DI B-00810087180072), active as of 23 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-00810087180072 00810087180072 | Date22 May 2026 | StatusActive |
Official records
- EUDAMED public site B-00810087180072
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- FARADRIVE Steerable Sheath (clear)
- Model / reference
- 21M402
- Primary DI / UDI-DI
- 00810087180072
- Basic UDI-DI
- B-00810087180072
- EMDN code
- C0502 Cardiovascular introducer sheaths, valved
- Device class
- Class III
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000017969
- Authorised representative
- ICON (LR) Limited IE-AR-000006507
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