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GRAFIA Angiographic catheter

by Sungjin-Hitech Co., Ltd 513 variants

Ref SJ-AC4-AL2-100

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 23 Oct 2026. What this means

Overview

The GRAFIA Angiographic catheter is a high-quality, FDA-approved angiographic catheter designed for vascular interventions. This medical device is used to visualize the inner workings of blood vessels, allowing for accurate diagnosis and treatment of various cardiovascular conditions.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800023717310 Basic UDI-DI 08800023717310UDI-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  • Withdrawn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
SJ-AC4-AL2-100
Primary DI / UDI-DI
08800023717310
Basic UDI-DI
B-08800023717310
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

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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