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ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Short Amplatz Left 1.0cm, Si…
EUDAMEDClass III (EU MDR)
Ref HW80AL102P09002Ref HW80AL152P09002Ref HW80AL102P09000Ref HW80AL150P09000Ref HW80AL150P09002Ref HW80AL152P09000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Short Amplatz Left 1.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Short Amplatz Left 1.5cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Amplatz Left 1.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Amplatz Left 1.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Short Amplatz Left 1.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Amplatz Left 1.5cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80AL102P09002 EUDAMEDHW80AL152P09002 EUDAMEDHW80AL102P09000 EUDAMEDHW80AL150P09000 EUDAMEDHW80AL150P09002 EUDAMEDHW80AL152P09000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327104098 EUDAMED04547327104111 EUDAMED04547327103954 EUDAMED04547327103961 EUDAMED04547327104104 EUDAMED04547327103978 EUDAMED
- Basic UDI-DI
- B-04547327104098 EUDAMEDB-04547327104111 EUDAMEDB-04547327103954 EUDAMEDB-04547327103961 EUDAMEDB-04547327104104 EUDAMEDB-04547327103978 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, Short Amplatz Left 1.0cm, Si… 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-04547327104098 | 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 4dadc60a-8938-408f-b347-6dd1c1315363 61 fields · synced Oct 6, 2026
- EUDAMED 2ca8bf5f-66ee-4885-b2e2-2a92321c3c47 61 fields · synced May 16, 2026
- EUDAMED 59fba28b-b9c0-4b32-b5d9-7b04d338f925 61 fields · synced May 17, 2026
- EUDAMED 52eb65b7-e844-4149-a72e-f6a05ed7149a 61 fields · synced May 17, 2026
- EUDAMED a05a027a-d4ea-4afc-b826-18bafa8c65d3 61 fields · synced May 18, 2026
- EUDAMED 18222167-a033-40e2-821a-274db9646225 61 fields · synced May 19, 2026