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ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, RCA Backup 0.75cm
EUDAMEDClass III (EU MDR)
Ref HW70RB070P10000Ref HW70RB072P10000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, RCA Backup 0.75cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, RCA Backup 0.75cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW70RB070P10000 EUDAMEDHW70RB072P10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327103596 EUDAMED04547327103602 EUDAMED
- Basic UDI-DI
- B-04547327103596 EUDAMEDB-04547327103602 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, 7Fr, 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-04547327103596 | 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 09fe5c54-aa48-41b3-9090-48a00967e8e5 61 fields · synced Sep 17, 2026
- EUDAMED fdc1a834-059e-40c3-a13a-12d8c67c7c01 61 fields · synced May 18, 2026