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ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Power Backup 4.0cm
EUDAMEDClass III (EU MDR)
Ref HW80PB400P09000Ref HW80PB402P09000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Power Backup 4.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Power Backup 4.0cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80PB400P09000 EUDAMEDHW80PB402P09000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327104623 EUDAMED04547327104630 EUDAMED
- Basic UDI-DI
- B-04547327104623 EUDAMEDB-04547327104630 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 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-04547327104623 | 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 ec0b4079-0789-4d87-8dcb-240415d986cf 61 fields · synced Jul 13, 2026
- EUDAMED d45ac768-a8e5-44b0-aff7-5222d40af6ca 61 fields · synced May 18, 2026