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ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Power Backup 3.0cm
EUDAMEDClass III (EU MDR)
Ref HW70PB300P09000Ref HW70SP302P09000Ref HW70PB302P09000Ref HW70SP350P09000Ref HW70SP400P09000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Power Backup 3.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Super Power Backup 3.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Power Backup 3.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Super Power Backup 3.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Super Power Backup 4.0cm EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW70PB300P09000 EUDAMEDHW70SP302P09000 EUDAMEDHW70PB302P09000 EUDAMEDHW70SP350P09000 EUDAMEDHW70SP400P09000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327102971 EUDAMED04547327102766 EUDAMED04547327102988 EUDAMED04547327102773 EUDAMED04547327102797 EUDAMED
- Basic UDI-DI
- B-04547327102971 EUDAMEDB-04547327102766 EUDAMEDB-04547327102988 EUDAMEDB-04547327102773 EUDAMEDB-04547327102797 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, 7Fr, Power Backup 3.0cm 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-04547327102971 | 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 (5)
- EUDAMED cceed043-0c46-47c7-82d0-2037692ad745 61 fields · synced Oct 6, 2026
- EUDAMED 5411c511-427d-49ae-85c9-45b9bdd26e6d 61 fields · synced May 16, 2026
- EUDAMED 5fe3ca0c-56ff-4741-b7b7-d111ea0c7d52 61 fields · synced May 18, 2026
- EUDAMED e6a9d2ec-f156-4d44-a90c-6ea4a484d28c 61 fields · synced May 18, 2026
- EUDAMED 2de50d87-f5e7-45b2-b5e4-54a610152ed5 61 fields · synced May 19, 2026