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ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Power Backup 3.5cm
EUDAMEDClass III (EU MDR)
Ref HW80PB350P09000Ref HW80SP400P09000Ref HW80PB300P09000Ref HW80PB352P09000Ref HW80SP302P09000Ref HW80SP352P09000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Power Backup 3.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Super Power Backup 4.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Power Backup 3.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Power Backup 3.5cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Super Power Backup 3.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Super Power Backup 3.5cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80PB350P09000 EUDAMEDHW80SP400P09000 EUDAMEDHW80PB300P09000 EUDAMEDHW80PB352P09000 EUDAMEDHW80SP302P09000 EUDAMEDHW80SP352P09000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327104609 EUDAMED04547327104401 EUDAMED04547327104586 EUDAMED04547327104616 EUDAMED04547327104371 EUDAMED04547327104395 EUDAMED
- Basic UDI-DI
- B-04547327104609 EUDAMEDB-04547327104401 EUDAMEDB-04547327104586 EUDAMEDB-04547327104616 EUDAMEDB-04547327104371 EUDAMEDB-04547327104395 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, 8Fr, Power Backup 3.5cm 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-04547327104609 | 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 (6)
- EUDAMED e9fb1d4a-9485-45f4-a372-a4bc6a5ce1c6 61 fields · synced Oct 9, 2026
- EUDAMED 1fc7a310-fd26-4147-8404-b9111435db02 61 fields · synced May 18, 2026
- EUDAMED 93ee4c99-071e-496a-9d2a-2fdee159d4e2 61 fields · synced May 18, 2026
- EUDAMED fda09579-e66b-4f6c-85ee-dac34bf17368 61 fields · synced May 18, 2026
- EUDAMED 4a23ed96-9936-4e1c-a090-8acac520eb10 61 fields · synced May 19, 2026
- EUDAMED a1f398eb-52b1-4786-9eaf-9f75c0eb2225 61 fields · synced May 19, 2026