Identity
- Trade Name
- ASAHI Silverway EUDAMED
- Device Name
- ASAHI Silverway Hydrophilic Coated Spring Coil Guide Wire EUDAMED
- Model / Reference
- SJ1535N20S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327121309 EUDAMED
- Basic UDI-DI
- B-04547327121309 EUDAMED
- EMDN Code
- C04020201 PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, 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 Silverway 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-04547327121309 | 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 (1)
- EUDAMED d55861fe-5af2-49a5-81c5-038f3228571a 61 fields · synced May 23, 2026