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ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Judkins Left 4.0cm
EUDAMEDClass III (EU MDR)
Ref HW80JL400P09000Ref HW80JL402P09001Ref HW80JL402P09000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Judkins Left 4.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Judkins Left 4.0cm, Short Tip, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 8Fr, Judkins Left 4.0cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80JL400P09000 EUDAMEDHW80JL402P09001 EUDAMEDHW80JL402P09000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327104876 EUDAMED04547327104890 EUDAMED04547327104883 EUDAMED
- Basic UDI-DI
- B-04547327104876 EUDAMEDB-04547327104890 EUDAMEDB-04547327104883 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, 90cm, 8Fr, 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-04547327104876 | 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 e1c8161a-1c48-40be-abc3-261a4692516d 61 fields · synced Sep 17, 2026
- EUDAMED b305f0b1-edd1-4ac0-be98-555b55ddf978 61 fields · synced May 17, 2026
- EUDAMED fd2e2f00-1883-4a88-84a0-c639676f302f 61 fields · synced May 17, 2026