Fubuki Xf
by Asahi Intecc Co., Ltd. 16 variants
Part of a family of 76 devices: see the family page
Ref FBKX-8A100
Fubuki Xf (FBKX-8A100) is a Class III device made by Asahi Intecc Co., Ltd., registered in EUDAMED on 25 May 2026 (Basic UDI-DI 4547327AGC023HN), active as of 7 Nov 2026.
Active
CE MDR
Valid until
17 Mar 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4547327AGC023HN 04547327161190 | Date25 May 2026 | StatusActive |
Official records
- EUDAMED public site 4547327AGC023HN
Certificates
- MDR 792853 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 18 Mar 2026
- Expires
- 17 Mar 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- FUBUKI Series NEUROVASCULAR GUIDE CATHETER NEUROVASCULAR LONG SHEATH
- Model / reference
- FBKX-8A100
- Primary DI / UDI-DI
- 04547327161190
- Basic UDI-DI
- 4547327AGC023HN
- EMDN code
- C0104020204 Peripheral angiography guide catheters
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- JP-MF-000010199
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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