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Low Contrast Test Tool

by Sun Nuclear Corporation

Ref 200

Low Contrast Test Tool (200) is a Class I device made by Sun Nuclear Corporation, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 506060888200PHQX), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506060888200PHQX Basic UDI-DI 05060608881291UDI-DIDate2 Jul 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
200
Primary DI / UDI-DI
05060608881291
Basic UDI-DI
506060888200PHQX
EMDN code
Z11030599 Radiology instruments - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000021541
Authorised representative
Sun Nuclear GmbH DE-AR-000012933

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Properties

Other properties (14, all answered No)