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Argi̇ Grup

by Argi̇ Grup Sağlik Hi̇zmetleri̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ 6 variants

Ref ARG12001PLModel Pediatric 7F

Active European Union

CE MDR

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 Number86987537ARG12001PLNW Basic UDI-DI 08698753710271UDI-DIDate8 Jul 2025RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
CSF External Ventricular Dranaige and ICP Monitoring System Pediatric 7F
CSF External Ventricular Dranaige and ICP Monitorization System
Model / Reference
ARG12001PL, Pediatric 7F
Primary DI / UDI-DI
08698753710271
Basic UDI-DI
86987537ARG12001PLNW, B-08698753710271
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