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ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 5.0cm, Side Ho…
EUDAMEDClass III (EU MDR)
Ref HW70JL502P10000Ref HW70JL500P10001Ref HW70JL500P10000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 5.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 5.0cm, Short Tip EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Judkins Left 5.0cm EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW70JL502P10000 EUDAMEDHW70JL500P10001 EUDAMEDHW70JL500P10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327103213 EUDAMED04547327103206 EUDAMED04547327103190 EUDAMED
- Basic UDI-DI
- B-04547327103213 EUDAMEDB-04547327103206 EUDAMEDB-04547327103190 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 5.0cm, 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-04547327103213 | 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 34af8df4-8d30-49d9-944e-48a7af6c6566 61 fields · synced Oct 6, 2026
- EUDAMED 27ce1f50-1428-4213-b420-5f4ee9c92092 61 fields · synced May 16, 2026
- EUDAMED 5ab5ba62-c4f0-44d9-a02c-b2b980ab0b51 61 fields · synced May 17, 2026