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DoseView 3D Helical

by Standard Imaging, Inc.

Ref 92250

Expiring European Union

CE MDR

Valid until

18 Oct 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08665620002DOSEVIEWZD Basic UDI-DI 00850019946642UDI-DIDate16 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620136130-01 Expiring Expires in 348 days

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    22 Feb 2023
    Expires
    18 Oct 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
QA Water Phantom
Model / Reference
92250
Primary DI / UDI-DI
00850019946642
Basic UDI-DI
08665620002DOSEVIEWZD
EMDN Code
Z11010180 Linear accelerators - hardware accessories
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000009855
Authorised representative
Hoff & Lowendahl AB SE-AR-000001888

Other devices from Standard Imaging, Inc.

See all devices from Standard Imaging, Inc. →

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