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CSF External Lumbar Dranaige and ICP Monitorization System

by Argi̇ Grup Sağlik Hi̇zmetleri̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref ARG11001PLModel 4F

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-08698753710233 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 23 Oct 2026

Trade Name
Argi̇ Grup
Device Name
CSF External Lumbar Dranaige and ICP Monitorization System
CSF External Lumbar Dranaige and ICP Monitoring System 4F
Model / Reference
4F, ARG11001PL
Primary DI / UDI-DI
08698753710233
Basic UDI-DI
B-08698753710233, 86987537ARG11001PLNH
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 0454d1b8-962b-4b22-b764-2775545d20d5 61 fields · synced 23 Oct 2026
  • EUDAMED 08698753710233|86987537ARG11001PLNH 61 fields · synced 18 May 2026