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ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Amplatz Left 1.5cm
EUDAMEDClass III (EU MDR)
Ref HW70AL150P09000Ref HW70AL100P09000Ref HW70AL152P09000Ref HW70AL102P09000
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Amplatz Left 1.5cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Amplatz Left 1.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Amplatz Left 1.5cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 90cm, 7Fr, Amplatz Left 1.0cm, Side Hole EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW70AL150P09000 EUDAMEDHW70AL100P09000 EUDAMEDHW70AL152P09000 EUDAMEDHW70AL102P09000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327102353 EUDAMED04547327102339 EUDAMED04547327102360 EUDAMED04547327102346 EUDAMED
- Basic UDI-DI
- B-04547327102353 EUDAMEDB-04547327102339 EUDAMEDB-04547327102360 EUDAMEDB-04547327102346 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, Amplatz Left 1.5cm 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-04547327102353 | 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 (4)
- EUDAMED 7f2df695-083c-4176-9a5c-ae95328fca16 61 fields · synced Aug 4, 2026
- EUDAMED df86d67c-ec4f-4f73-bee4-1a17a88abb34 61 fields · synced May 17, 2026
- EUDAMED f899c162-cef4-4ae0-b969-91c7f5321802 61 fields · synced May 18, 2026
- EUDAMED 90a88a06-c281-491e-9023-5047b6992807 61 fields · synced May 18, 2026