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Guidewire

by Shanghai INT Medical Instruments Co., Ltd. China EUDAMED

Ref GW321SFModel 0.018", 0.021", 0.025", 0.028", 0.032", 0.035", 0.038"

EMDN C04020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69509009CEAGWMN Basic UDI-DIDate24 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Guidewire
Model / Reference
0.018", 0.021", 0.025", 0.028", 0.032", 0.035", 0.038", GW321SF
Primary DI / UDI-DI
06950900957550
Basic UDI-DI
69509009CEAGWMN
EMDN Code
C04020102 Peripheral vascular diagnostic guidewires, non-hydrophilic
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000009966
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shanghai INT Medical Instruments Co., Ltd.

See all devices from Shanghai INT Medical Instruments 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 38a139cc-3203-4f01-9661-a4c3612f8466 61 fields · synced 24 Oct 2026