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CSF External Lumbar Dranaige and ICP Monitorization System

by Argi̇ Grup Sağlik Hi̇zmetleri̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref ARG11002PLModel Pediatric/Adult 4,5F

EMDN N02010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR.2292-2025/0021 Date30 Jun 2025IssuedStatusActive expires 29 Jun 2030
European UnionCE/MDD NumberB-08698753710240 Basic UDI-DIDate27 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates

1 certificate · EUDAMED

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

    Technical documentation EU MDR

    Notified body
    Notified body 2292
    Issued
    30 Jun 2025
    Expires
    29 Jun 2030
    Valid from
    9 Jul 2025

Specification

EUDAMED · synced 24 Oct 2026

Trade Name
Argi̇ Grup
Device Name
CSF External Lumbar Dranaige and ICP Monitorization System
CSF External Lumbar Dranaige and ICP Monitoring System Pediatric/Adult 4,5F
Model / Reference
Pediatric/Adult 4, 5F, ARG11002PL
Primary DI / UDI-DI
08698753710240
Basic UDI-DI
B-08698753710240, 86987537ARG11002PLNN
EMDN Code
N02010199 Peridural / epidural spinal catheters and kits - other
Device Class
Class III
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 & 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 ee1c1adf-c8ab-4482-8c90-ad83c16f185b 61 fields · synced 24 Oct 2026
  • EUDAMED 08698753710240|86987537ARG11002PLNN 61 fields · synced 18 May 2026