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ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Right 4.0cm
EUDAMEDClass III (EU MDR)
Ref HW80JR400P10000Ref HW80JR402P10000Ref HW80JR452P10000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Right 4.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Right 4.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Right 4.5cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80JR400P10000 EUDAMEDHW80JR402P10000 EUDAMEDHW80JR452P10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327104920 EUDAMED04547327104937 EUDAMED04547327104951 EUDAMED
- Basic UDI-DI
- B-04547327104920 EUDAMEDB-04547327104937 EUDAMEDB-04547327104951 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 Right 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-04547327104920 | 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 dddb54f1-8866-4d14-976d-f6125a64d620 61 fields · synced Jul 10, 2026
- EUDAMED f32adb15-a6ed-4185-a1a2-36d8a6d8fb5d 61 fields · synced May 16, 2026
- EUDAMED 4f479649-41ca-4972-886a-144ed12d8fa1 61 fields · synced May 18, 2026