Skip to content

Episol-V

by GS Medical Co., Ltd. South Korea EUDAMED

Ref GSCG-1701-1802, GSCG-1701-1802-CE(0)Model EPISOL, NECS-GV1100

EMDN N02010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number880010402258 Basic UDI-DIDate9 Dec 2024RegisteredStatusActive
European UnionCE/MDR Number880010402258 Basic UDI-DIDate9 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
EPISOL, GSCG-1701-1802, NECS-GV1100, GSCG-1701-1802-CE(0)
Primary DI / UDI-DI
08806395470419
Basic UDI-DI
880010402258, B-08806395470419
EMDN Code
N02010101 Epiduroscopy and epiduroplastics catheters and kits
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000029960
Authorised representative
Obelis s.a. BE-AR-000000106

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 (2)

  • EUDAMED d8fb6de0-0fb3-48aa-a5ef-fc5471520ae6 61 fields · synced 22 Oct 2026
  • EUDAMED 62820adc-3643-4d30-8f25-da5d466e2dd8 61 fields · synced 12 Jul 2026