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GRAFIA Angiographic catheter

by Sungjin-Hitech Co., Ltd South Korea EUDAMED

Ref EL-AC5-P180-080-5s

EMDN C0104020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800023702125 Basic UDI-DIDate28 May 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

Model / Reference
EL-AC5-P180-080-5s
Primary DI / UDI-DI
08800023702125
Basic UDI-DI
B-08800023702125
EMDN Code
C0104020101 Panoramic and selective peripheral diagnostic angiography catheters and microcatheters
Device Class
Class III
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
KR-MF-000036002
Authorised representative
Meridius Medical Europe Limited IE-AR-000004258

Other devices from Sungjin-Hitech Co., Ltd

See all devices from Sungjin-Hitech 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 7ed1fe93-f784-481f-b397-3573ed214003 61 fields · synced 22 Oct 2026