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ASAHI Silverway
EUDAMEDClass III (EU MDR)
Ref SJ1535N22SRef SJ3035N22SRef SJ1535N15SRef SA0035N22SRef SA0035N18SRef SJ3035N15SRef SJ3035N20SRef SA0035N15SRef SJ1535N26SRef SJ3035N26SRef SA0035N20SRef SA0035N26S
Identity
- Trade Name
- ASAHI Silverway EUDAMED
- Device Name
- ASAHI Silverway Hydrophilic Coated Spring Coil Guide Wire EUDAMED
- Model / Reference
- SJ1535N22S EUDAMEDSJ3035N22S EUDAMEDSJ1535N15S EUDAMEDSA0035N22S EUDAMEDSA0035N18S EUDAMEDSJ3035N15S EUDAMEDSJ3035N20S EUDAMEDSA0035N15S EUDAMEDSJ1535N26S EUDAMEDSJ3035N26S EUDAMEDSA0035N20S EUDAMEDSA0035N26S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327121316 EUDAMED04547327121378 EUDAMED04547327121286 EUDAMED04547327121439 EUDAMED04547327121415 EUDAMED04547327121347 EUDAMED04547327121361 EUDAMED04547327121408 EUDAMED04547327121323 EUDAMED04547327121385 EUDAMED04547327121422 EUDAMED04547327121446 EUDAMED
- Basic UDI-DI
- B-04547327121316 EUDAMEDB-04547327121378 EUDAMEDB-04547327121286 EUDAMEDB-04547327121439 EUDAMEDB-04547327121415 EUDAMEDB-04547327121347 EUDAMEDB-04547327121361 EUDAMEDB-04547327121408 EUDAMEDB-04547327121323 EUDAMEDB-04547327121385 EUDAMEDB-04547327121422 EUDAMEDB-04547327121446 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-04547327121316 | 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 (12)
- EUDAMED d49027d7-ea99-4ac7-81d5-828952ec11fe 61 fields · synced Sep 18, 2026
- EUDAMED 08df479d-a8eb-4d67-8cec-0f163619a0ea 61 fields · synced May 11, 2026
- EUDAMED d0062219-e69b-4025-a5cd-5ba3fab9c7c2 61 fields · synced May 16, 2026
- EUDAMED 3173cf74-4a00-4d7a-97f3-f6ef926012c5 61 fields · synced May 16, 2026
- EUDAMED 43374ec7-9f42-4e9e-b8f8-d498ca5de908 61 fields · synced May 17, 2026
- EUDAMED 91a0f31b-7e88-459b-bec5-5326f24fabe0 61 fields · synced May 17, 2026
- EUDAMED 7ba0e638-4fa4-40b8-b920-9e06028d02ee 61 fields · synced May 17, 2026
- EUDAMED 2b1cd466-f969-4c0d-8c4f-5321686915e6 61 fields · synced May 18, 2026
- EUDAMED 69896037-a785-4af5-ad10-cc46e832cefc 61 fields · synced May 18, 2026
- EUDAMED 33bddef3-b1c6-4896-9161-7d34394a8565 61 fields · synced May 18, 2026
- EUDAMED 4e13325a-a984-417d-9a10-769102ebba0a 61 fields · synced May 18, 2026
- EUDAMED a9642426-f956-49b9-80a8-dd11e1184865 61 fields · synced May 19, 2026