Skip to content

BRIGHTER Medical Imaging Platform

by Graylight Imaging Spółka Z Ograniczoną Odpowiedzialnością

Ref 1.0

Active European Union

CE MDR

Valid until

4 Aug 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TUV NORD Polska Sp. z o.o

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 Number5903829699BRIGHTERLK Basic UDI-DI 05903829699002UDI-DIDate7 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TNP/MDR/0061/5798/2026 Active

    Quality management system EU MDR

    Certifier
    TUV NORD Polska Sp. z o.o 2274
    Issued
    5 Aug 2026
    Expires
    4 Aug 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
BRIGHTER Medical Imaging Platform
Model / Reference
1.0
Primary DI / UDI-DI
05903829699002
Basic UDI-DI
5903829699BRIGHTERLK
Direct Marketing DI
05903829699002
EMDN Code
Z11030592 Radiology instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000048205

Other devices from Graylight Imaging Spółka Z Ograniczoną Odpowiedzialnością

  • Cs Gated

    Class IIa

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No