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ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Special Curve 4.0cm
EUDAMEDClass III (EU MDR)
Ref HW80SC400P10000Ref HW80SC402P10000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Special Curve 4.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Special Curve 4.0cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80SC400P10000 EUDAMEDHW80SC402P10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327105064 EUDAMED04547327105071 EUDAMED
- Basic UDI-DI
- B-04547327105064 EUDAMEDB-04547327105071 EUDAMED
- EMDN Code
- C0104010202 CARDIAC 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 Hyperion Coronary Guide Catheter, 100cm, 8Fr, Special Curve 4.0cm 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-04547327105064 | 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 (2)
- EUDAMED c8e23f52-d5b4-4c33-b0f3-db20440431bf 61 fields · synced Jul 20, 2026
- EUDAMED d1e8039b-711e-463a-8189-ede5341ebee1 61 fields · synced May 18, 2026