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Mammo 145 FFDM Phantom

by Sun Nuclear Corporation

Ref 145

Mammo 145 FFDM Phantom is a Class I device made by Sun Nuclear Corporation, registered in EUDAMED on 19 Nov 2025 (Basic UDI-DI 506060888PH1454J), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506060888PH1454J Basic UDI-DI 05060608881239UDI-DIDate19 Nov 2025RegisteredStatusActive

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  • Withdrawn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
145
Primary DI / UDI-DI
05060608881239
Basic UDI-DI
506060888PH1454J
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)