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Boluslab

by Techforge International Sp. z o.o. EUDAMED

Active European Union

Ref BL-RT-SW-1.3.X

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5905200BoluslabKQ Basic UDI-DIDate2 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Boluslab Software Application
Model / Reference
BL-RT-SW-1.3.X
Primary DI / UDI-DI
05905200018723
Basic UDI-DI
5905200BoluslabKQ
Direct Marketing DI
05905200018723
EMDN Code
Z11010482 Radiotherapy treatment planning instruments - software accessories
Device Class
Class I
Special Device Type
Software
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000059603

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