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CR500

by DIGIRAY Corp.

Ref CR500

CR500 is a Class IIa device made by Digiray Corp., registered in EUDAMED on 12 Jun 2026 (Basic UDI-DI 08809466041284A), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08809466041284A Basic UDI-DI 08809466041280UDI-DIDate12 Jun 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
CR500
Primary DI / UDI-DI
08809466041280
Basic UDI-DI
08809466041284A
EMDN code
Z11060201 Single-input computed radiography (cr) systems
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000024601
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS.

Other devices from Digiray Corp.

See all devices from Digiray Corp. →

Properties

Other properties (14, all answered No)