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ASAHI PTCA Guide Wire ASAHI SION J
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref AHW14R001J
Identity
- Trade Name
- ASAHI PTCA Guide Wire ASAHI SION J EUDAMED
- Device Name
- ASAHI PTCA Guide Wire ASAHI SION and SUOH 03 EUDAMED
- Model / Reference
- AHW14R001J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327086202 EUDAMED
- Basic UDI-DI
- B-04547327086202 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 J by Asahi Intecc Co., Ltd. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070945 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K052339 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327086202 | 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 de9cd78d-ffcc-461a-b70a-a30862dd99fc 61 fields · synced Jul 23, 2026
- FDA 510(k) K070945 1 fields · synced May 18, 2026