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ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, RCA Backup 0.75cm
EUDAMEDClass III (EU MDR)
Ref HW80RB070P10000Ref HW80RB072P10000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, RCA Backup 0.75cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, RCA Backup 0.75cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80RB070P10000 EUDAMEDHW80RB072P10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327105200 EUDAMED04547327105217 EUDAMED
- Basic UDI-DI
- B-04547327105200 EUDAMEDB-04547327105217 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, RCA Backup 0.75cm 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-04547327105200 | 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 a3cd10dc-4587-4370-9f13-8ffad342cfa4 61 fields · synced Jul 30, 2026
- EUDAMED 1f05225a-b953-49f7-a81c-cb547a740c08 61 fields · synced May 18, 2026