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Scolioscan

by Telefield Medical Imaging Limited

Ref SCN803, SCN201

Active European Union

CE MDR

Valid until

14 Apr 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN25/00002377 Date14 Apr 2025IssuedStatusActive expires 14 Apr 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN25/00002377 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    14 Apr 2025
    Expires
    14 Apr 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Scolioscan Air
Model / Reference
SCN803, SCN201
Primary DI / UDI-DI
04897122688034, 04897122680014
Basic UDI-DI
489712268SCN803KW, 489712268SCN201JU
Direct Marketing DI
04897122688034
04897122680014
EMDN Code
Z11040106, Z11040103
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
HK-MF-000019519
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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