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ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Short Amplatz Left 1.0cm
EUDAMEDClass III (EU MDR)
Ref HW80AL100P10002Ref HW80AL070P10002Ref HW80AL150P10000Ref HW80AL102P10000Ref HW80AL102P10002
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Short Amplatz Left 1.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Short Amplatz Left 0.75cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Amplatz Left 1.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Amplatz Left 1.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Short Amplatz Left 1.0cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80AL100P10002 EUDAMEDHW80AL070P10002 EUDAMEDHW80AL150P10000 EUDAMEDHW80AL102P10000 EUDAMEDHW80AL102P10002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327104005 EUDAMED04547327103985 EUDAMED04547327103848 EUDAMED04547327103824 EUDAMED04547327104012 EUDAMED
- Basic UDI-DI
- B-04547327104005 EUDAMEDB-04547327103985 EUDAMEDB-04547327103848 EUDAMEDB-04547327103824 EUDAMEDB-04547327104012 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, Short Amplatz Left 1.0cm 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-04547327104005 | 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 b794d27d-e43e-4ac3-a69f-58c8e06b4ee2 61 fields · synced Jul 24, 2026
- EUDAMED c06528ec-ad26-488c-9b85-3600b8d8eca8 61 fields · synced May 17, 2026
- EUDAMED ce881ff7-3024-4f66-826c-440982d65c2d 61 fields · synced May 17, 2026
- EUDAMED 3200178f-7e9d-4b98-82a5-9e946ace837c 61 fields · synced May 18, 2026
- EUDAMED 19d127b2-8e8c-4e80-9d8f-657ceec4cf98 61 fields · synced May 18, 2026