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SpineQ

by Bonescreen GmbH Germany EUDAMED

Ref SpineQ v1.1.0, SpineQ v1.2.0 EMDN Z11030582

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberZ-24-007-S-E Date6 Jun 2025IssuedStatusWithdrawn No longer placed on the EU market expires 5 Jun 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • Z-24-007-S-E Issued

    Quality management system EU MDR

    Notified body
    Notified body 0633
    Issued
    6 Jun 2025
    Expires
    5 Jun 2030

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SpineQ v1.1.0, SpineQ v1.2.0
Primary DI / UDI-DI
04262470340017, 04262470340024
Basic UDI-DI
426247034BS00001QE
Direct Marketing DI
04262470340017
04262470340024
EMDN Code
Z11030582 Radiology instruments - software accessories
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000036576

Other devices from Bonescreen GmbH

  • SpineQ

    Class IIa

  • SpineQ

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 6bd8f664-2406-44dd-a6cf-5f2b0c078d6a 61 fields · synced 24 Oct 2026
  • EUDAMED 04262470340024|426247034BS00001QE 61 fields · synced 18 May 2026