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ASAHI PTCA Guide Wire ASAHI SION blue ES 300cm Pre-shape
EUDAMEDClass III (EU MDR)
Ref AHW14R317PRef AHW14R317S
Identity
- Trade Name
- ASAHI PTCA Guide Wire ASAHI SION blue ES 300cm Pre-shape EUDAMEDASAHI PTCA Guide Wire ASAHI SION blue ES 300cm EUDAMED
- Device Name
- ASAHI PTCA Guide Wire ASAHI SION and SUOH 03 EUDAMED
- Model / Reference
- AHW14R317P EUDAMEDAHW14R317S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327133067 EUDAMED04547327108577 EUDAMED
- Basic UDI-DI
- B-04547327133067 EUDAMEDB-04547327108577 EUDAMED
- EMDN Code
- C04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC 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 PTCA Guide Wire ASAHI SION blue ES 300cm Pre-shape by Asahi Intecc Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-04547327133067 | 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 3af8edc5-4e32-48c0-8cb8-498b1a2edb22 61 fields · synced Aug 2, 2026
- EUDAMED 9928cf40-4a08-4503-8258-23189a7a8e97 61 fields · synced May 17, 2026