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Upgrade Marlin

by Philips Medical Systems Nederland B.V.

Ref 782188

Active European Union

CE MDR

Valid until

1 May 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2243595CE01 Date24 Sep 2026IssuedStatusActive expires 1 May 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243595CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    24 Sep 2026
    Expires
    1 May 2030
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Marlin 1.5T
Model / Reference
782188
Primary DI / UDI-DI
00884838125827
Basic UDI-DI
0884838BM938TY
Direct Marketing DI
00884838125827
EMDN Code
Z11050104 Closed magnet MRI scanners with magnetic field less than or equal to 2t
Device Class
Class IIb
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

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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