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ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Short Amplatz Left 2.0cm
EUDAMEDClass III (EU MDR)
Ref HW70AL200P10002Ref HW70AL100P10002Ref HW70AL102P10002Ref HW70AL070P10002
Identity
- Trade Name
- ASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Short Amplatz Left 2.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Short Amplatz Left 1.0cm EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Short Amplatz Left 1.0cm, Side Hole EUDAMEDASAHI Hyperion Coronary Guide Catheter, 100cm, 7Fr, Short Amplatz Left 0.75cm EUDAMED
- Device Name
- ASAHI Hyperion Coronary Guide Catheter EUDAMED
- Model / Reference
- HW70AL200P10002 EUDAMEDHW70AL100P10002 EUDAMEDHW70AL102P10002 EUDAMEDHW70AL070P10002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327102438 EUDAMED04547327102391 EUDAMED04547327102407 EUDAMED04547327102377 EUDAMED
- Basic UDI-DI
- B-04547327102438 EUDAMEDB-04547327102391 EUDAMEDB-04547327102407 EUDAMEDB-04547327102377 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, Short Amplatz Left 2.0cm 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-04547327102438 | 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 36abc5df-04a5-49cc-a9d9-4f31a40e2362 61 fields · synced Jul 13, 2026
- EUDAMED 059334b0-1ff0-426b-a2b6-f5a1c1ebcea5 61 fields · synced May 17, 2026
- EUDAMED f5cda498-157f-4f04-9429-e5aa24bb98ba 61 fields · synced May 18, 2026
- EUDAMED 62f06b3e-8943-4ae8-a4ce-bf5656987f2d 61 fields · synced May 18, 2026