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Radiographic System

by Sedecal, S.A. (Sociedad Española De Electromedicina Y Calidad, S.A.) 25 variants

Ref TBFFModel MILLENNIUM, MULTIRAD, NOVA, CHALLENGE X, SALA, PROTEUS XR/f

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number843604600SYSTEMPS Basic UDI-DIDate7 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Radiographic System
Model / Reference
MILLENNIUM, MULTIRAD, NOVA, CHALLENGE X, SALA, PROTEUS XR/f, TBFF
Primary DI / UDI-DI
08436046003859
Basic UDI-DI
843604600SYSTEMPS
EMDN Code
Z11039005 Radiogenic complexes
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
ES-MF-000017998

Other devices from Sedecal, S.A. (Sociedad Española De Electromedicina Y Calidad, S.A.)

See all devices from Sedecal, S.A. (Sociedad Española De Electromedicina Y Calidad, S.A.) →

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