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ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 4.0cm
EUDAMEDClass III (EU MDR)
Ref HW70JL400P10000Ref HW70JL450P10001Ref HW70JL452P10000Ref HW70JL402P10000Ref HW70JL450P10000Ref HW70JL402P10001
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 4.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 4.5cm, Short Tip EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 4.5cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 4.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 4.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 4.0cm, Short Tip, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW70JL400P10000 EUDAMEDHW70JL450P10001 EUDAMEDHW70JL452P10000 EUDAMEDHW70JL402P10000 EUDAMEDHW70JL450P10000 EUDAMEDHW70JL402P10001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327103114 EUDAMED04547327103169 EUDAMED04547327103176 EUDAMED04547327103138 EUDAMED04547327103152 EUDAMED04547327103145 EUDAMED
- Basic UDI-DI
- B-04547327103114 EUDAMEDB-04547327103169 EUDAMEDB-04547327103176 EUDAMEDB-04547327103138 EUDAMEDB-04547327103152 EUDAMEDB-04547327103145 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, 7Fr, Judkins Left 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-04547327103114 | 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 ebb198ea-cd0b-4530-b049-936439a287fb 61 fields · synced Jul 27, 2026
- EUDAMED 824b0fb6-a891-4eef-ad34-c434c20e3c39 61 fields · synced May 16, 2026
- EUDAMED 6c2abad9-4109-4bca-a207-1d73908d60b0 61 fields · synced May 17, 2026
- EUDAMED d20bc7bb-360f-48d4-8624-ea44cda6e09b 61 fields · synced May 17, 2026
- EUDAMED 55d3a3c0-849a-4cc3-84b5-0f5dbbc01ae9 61 fields · synced May 18, 2026
- EUDAMED bbb5abfa-e605-45c9-b692-5cbe4629745c 61 fields · synced May 18, 2026