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ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Amplatz Right 2.0cm
EUDAMEDClass III (EU MDR)
Ref HW80AR200P10000Ref HW80AR202P10000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Amplatz Right 2.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Amplatz Right 2.0cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80AR200P10000 EUDAMEDHW80AR202P10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327105101 EUDAMED04547327105118 EUDAMED
- Basic UDI-DI
- B-04547327105101 EUDAMEDB-04547327105118 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, Amplatz Right 2.0cm 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-04547327105101 | 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 eda2047b-93a7-422f-876b-8e10a83337d0 61 fields · synced Jul 14, 2026
- EUDAMED 82bdb9c2-e27a-4afd-975d-2a4fe45d9111 61 fields · synced May 18, 2026