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SagiPlan® Treatment Planning System, preconfigured Notebook FR

by BEBIG Medical GmbH

Ref 1374-0622

Active European Union

CE MDR

Valid until

16 Nov 2028

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number40659830002BC3 Basic UDI-DI 04065983000078UDI-DIDate14 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2259103CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 May 2024
    Expires
    16 Nov 2028
    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  • Withdrawn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
SagiPlan®
Model / Reference
1374-0622
Primary DI / UDI-DI
04065983000078
Basic UDI-DI
40659830002BC3
EMDN Code
Z11010392 Brachytherapy radiation systems - medical device software
Device Class
Class IIb
Special Device Type
Software
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000012644

Other devices from BEBIG Medical GmbH

See all devices from BEBIG Medical GmbH →

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