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ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter…
EUDAMEDClass III (EU MDR)
Ref WAIN-FBK-4-120
Identity
- Trade Name
- ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit EUDAMED
- Device Name
- ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter/Dilator Kit EUDAMED
- Model / Reference
- WAIN-FBK-4-120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327098311 EUDAMED
- Basic UDI-DI
- B-04547327098311 EUDAMED
- EMDN Code
- C0104020204 PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria 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
ASAHI FUBUKI 043 Distal Support SystemASAHI FUBUKI Neurovascular Guide Catheter… by Asahi Intecc Co., Ltd. — Class III — MDD — listed in EUDAMED
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-04547327098311 | Class III | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
- EUDAMED SRN
- JP-MF-000010199
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 698bc577-8af1-4379-9c6b-de81db1d9194 61 fields · synced Jun 19, 2026