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CSF External Ventricular Dranaige and ICP Monitorization System

by Argi̇ Grup Sağlik Hi̇zmetleri̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ 5 variants

Ref ARG12003PLModel 9F

Active European Union

CE MDR CE MDD

Valid until

29 Jun 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR.2292-2025/0021 Date30 Jun 2025IssuedStatusActive expires 29 Jun 2030
European UnionCE/MDD NumberB-08698753710295 Basic UDI-DI 08698753710295UDI-DIDate27 Nov 2024RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2025/0021 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    30 Jun 2025
    Expires
    29 Jun 2030
    Valid from
    9 Jul 2025

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade Name
Argi̇ Grup
Device Name
CSF External Ventricular Dranaige and ICP Monitorization System
CSF External Ventricular Dranaige and ICP Monitoring System Adult 9F
Model / Reference
9F, ARG12003PL
Primary DI / UDI-DI
08698753710295
Basic UDI-DI
B-08698753710295, 86987537ARG12003PLP8
EMDN Code
A060201 External drainage catheters and kits (abscesses, gallstones, cysts)
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000039631

Other devices from Argi̇ Grup Sağlik Hi̇zmetleri̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Argi̇ Grup Sağlik Hi̇zmetleri̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

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