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BrainScan CT

by Brainscan Spółka Akcyjna EUDAMED

Active European Union

Ref BrainScan CT 1.3

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberTNP/MDR/0046/4823/2026 Date3 Feb 2026IssuedStatusActive expires 6 Feb 2029

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TNP/MDR/0046/4823/2026 Reissued

    Quality management system EU MDR

    Notified body
    TUV NORD Polska Sp. z o.o 2274
    Issued
    3 Feb 2026
    Expires
    6 Feb 2029
    Valid from
    7 Feb 2026

Specification

EUDAMED

Model / Reference
BrainScan CT 1.3
Primary DI / UDI-DI
05903699822623, 05903699822616
Basic UDI-DI
59036998226BrainscanCTFC
Direct Marketing DI
05903699822623
05903699822616
EMDN Code
Z11030682 Computed tomographs (CT) - software accessories
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000022152

Properties

Other properties (13)

  • Sterile: No
  • 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