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GRAFIA Angiographic catheter

by Sungjin-Hitech Co., Ltd 513 variants

Ref RA-AC5-HN5-100

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Overview

The GRAFIA Angiographic catheter is a high-quality, FDA-cleared device designed for accurate and safe angiographic imaging of coronary arteries. It features a durable design, advanced technology, and user-friendly interface, making it an ideal choice for medical professionals and patients alike.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800023703542 Basic UDI-DI 08800023703542UDI-DIDate28 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
RA-AC5-HN5-100
Primary DI / UDI-DI
08800023703542
Basic UDI-DI
B-08800023703542
EMDN Code
C0104020101 Panoramic and selective peripheral diagnostic angiography catheters and microcatheters
Device Class
Class III
EU 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

  • 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