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ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 4.5cm, Side Ho…
EUDAMEDClass III (EU MDR)
Ref HW80JL452P10000Ref HW80JL402P10000Ref HW80JL402P10001Ref HW80JL450P10000Ref HW80JL400P10001
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 4.5cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 4.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 4.0cm, Short Tip, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 4.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 4.0cm, Short Tip EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80JL452P10000 EUDAMEDHW80JL402P10000 EUDAMEDHW80JL402P10001 EUDAMEDHW80JL450P10000 EUDAMEDHW80JL400P10001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327104784 EUDAMED04547327104746 EUDAMED04547327104753 EUDAMED04547327104760 EUDAMED04547327104739 EUDAMED
- Basic UDI-DI
- B-04547327104784 EUDAMEDB-04547327104746 EUDAMEDB-04547327104753 EUDAMEDB-04547327104760 EUDAMEDB-04547327104739 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, Judkins Left 4.5cm, Side Ho… 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-04547327104784 | 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 706f1ff9-19a7-4aad-82e7-4cddf3d42432 61 fields · synced Sep 18, 2026
- EUDAMED b7a0b52d-7c63-46ae-bc08-84c755ceac7e 61 fields · synced May 18, 2026
- EUDAMED 19c96018-4d99-4223-955a-0229bfbd4b22 61 fields · synced May 18, 2026
- EUDAMED 3671a4f8-65da-437e-bef8-cc7148609b0f 61 fields · synced May 18, 2026
- EUDAMED 24382cd7-b9a3-46de-9ed3-9c00e9aee7a0 61 fields · synced May 19, 2026