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ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Power Backup 4.0cm
EUDAMEDClass III (EU MDR)
Ref HW70PB400P10000Ref HW70SP402P10000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Power Backup 4.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Super Power Backup 4.0cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW70PB400P10000 EUDAMEDHW70SP402P10000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327102919 EUDAMED04547327102704 EUDAMED
- Basic UDI-DI
- B-04547327102919 EUDAMEDB-04547327102704 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, Power Backup 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-04547327102919 | 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 (2)
- EUDAMED 96ff3496-0cd5-43bb-977b-269f0d4569df 61 fields · synced Jul 16, 2026
- EUDAMED 32837ba4-b395-4c50-91c1-170c9e0fb261 61 fields · synced May 19, 2026