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ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Shepherd's Crook 3.5cm, Sid…
EUDAMEDClass III (EU MDR)
Ref HW80SA352P10000Ref HW80SA400P10000Ref HW80SA350P10000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Shepherd's Crook 3.5cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Shepherd's Crook 4.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Shepherd's Crook 3.5cm EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80SA352P10000 EUDAMEDHW80SA400P10000 EUDAMEDHW80SA350P10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327105132 EUDAMED04547327105149 EUDAMED04547327105125 EUDAMED
- Basic UDI-DI
- B-04547327105132 EUDAMEDB-04547327105149 EUDAMEDB-04547327105125 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, Shepherd's Crook 3.5cm, Sid… 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-04547327105132 | 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 (3)
- EUDAMED 095198f3-c3ce-4b68-a56c-4f71621b7e9a 61 fields · synced Jul 28, 2026
- EUDAMED 10bcaf7d-e3ed-432c-8ee6-9f9a384573e0 61 fields · synced May 18, 2026
- EUDAMED bbb5abbf-df91-45bb-b913-0ca86317b475 61 fields · synced May 18, 2026