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ASAHI Silverway

by Asahi Intecc Co., Ltd. United States EUDAMED

Ref SJ3035N20S

EMDN C04020201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04547327121361 Basic UDI-DIDate15 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
ASAHI Silverway Hydrophilic Coated Spring Coil Guide Wire
Model / Reference
SJ3035N20S
Primary DI / UDI-DI
04547327121361
Basic UDI-DI
B-04547327121361
EMDN Code
C04020201 Peripheral vascular therapeutic guidewires, hydrophilic
Device Class
Class III
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
JP-MF-000010199
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Asahi Intecc Co., Ltd.

See all devices from Asahi Intecc Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 7ba0e638-4fa4-40b8-b920-9e06028d02ee 61 fields · synced 22 Oct 2026