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ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 3.5cm, Side Ho…
EUDAMEDClass III (EU MDR)
Ref HW80JL352P10000Ref HW80JL350P10000Ref HW80JL300P10001Ref HW80JL350P10001Ref HW80JL352P10001Ref HW80JL302P10000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 3.5cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 3.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 3.0cm, Short Tip EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 3.5cm, Short Tip EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 3.5cm, Short Tip, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Judkins Left 3.0cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW80JL352P10000 EUDAMEDHW80JL350P10000 EUDAMEDHW80JL300P10001 EUDAMEDHW80JL350P10001 EUDAMEDHW80JL352P10001 EUDAMEDHW80JL302P10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327104708 EUDAMED04547327104685 EUDAMED04547327104654 EUDAMED04547327104692 EUDAMED04547327104715 EUDAMED04547327104661 EUDAMED
- Basic UDI-DI
- B-04547327104708 EUDAMEDB-04547327104685 EUDAMEDB-04547327104654 EUDAMEDB-04547327104692 EUDAMEDB-04547327104715 EUDAMEDB-04547327104661 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 3.5cm, 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-04547327104708 | 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 f6bfb473-7098-4270-b5d2-0ac62a1e840d 61 fields · synced Aug 2, 2026
- EUDAMED d1f8d899-e7ae-47e3-a177-fdca2c1ec87c 61 fields · synced May 18, 2026
- EUDAMED 9168f759-ad8a-4f8c-9b99-26d4de73f6fc 61 fields · synced May 18, 2026
- EUDAMED 7c82a519-db67-4385-b726-819e8380dcfc 61 fields · synced May 18, 2026
- EUDAMED d74a0190-a883-400b-82cb-0a11ff6009c3 61 fields · synced May 18, 2026
- EUDAMED abe8b9f4-52cd-4dd0-a6c1-0c6cb7277c09 61 fields · synced May 18, 2026