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ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Super Power Backup 4.0cm
EUDAMEDClass III (EU MDR)
Ref HW60SP400P09000Ref HW60SP350P09000Ref HW60SP302P09000Ref HW60SP402P09000Ref HW60PB402P09000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Super Power Backup 4.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Super Power Backup 3.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Super Power Backup 3.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Super Power Backup 4.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 6Fr, Power Backup 4.0cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW60SP400P09000 EUDAMEDHW60SP350P09000 EUDAMEDHW60SP302P09000 EUDAMEDHW60SP402P09000 EUDAMEDHW60PB402P09000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327101189 EUDAMED04547327101165 EUDAMED04547327101158 EUDAMED04547327101196 EUDAMED04547327101417 EUDAMED
- Basic UDI-DI
- B-04547327101189 EUDAMEDB-04547327101165 EUDAMEDB-04547327101158 EUDAMEDB-04547327101196 EUDAMEDB-04547327101417 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, 90cm, 6Fr, Super Power Backup 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-04547327101189 | 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 (5)
- EUDAMED bd090ac3-5807-460d-b836-01ba6218e48a 61 fields · synced Aug 1, 2026
- EUDAMED 88d790ab-7d8a-4ced-93df-1ed47c5a5a99 61 fields · synced May 17, 2026
- EUDAMED 36f08d23-0da0-45ce-a418-c2e471603414 61 fields · synced May 18, 2026
- EUDAMED 03099f69-57cf-4321-8cfc-d9cd644f7adb 61 fields · synced May 18, 2026
- EUDAMED 1441e25c-5520-4c0b-bdbb-90f1b9139f6f 61 fields · synced May 18, 2026