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Guide Wires

by Shunmei Medical Co., Ltd China EUDAMED

Ref 612130

EMDN C04020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06956014421307 Basic UDI-DIDate3 Jun 2026RegisteredStatusActive

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
Guide Wires
Model / Reference
612130
Primary DI / UDI-DI
06956014421307
Basic UDI-DI
B-06956014421307
EMDN Code
C04020102 Peripheral vascular diagnostic guidewires, non-hydrophilic
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000001160
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 5d39f816-b803-4784-bfd1-0384fd0e2718 61 fields · synced 22 Oct 2026