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Tomophan®

by Phantom Laboratory 3 variants

Ref TSP004

Active European Union

CE MDD

Valid until

Not listed

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

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/MDD NumberB-TSP004KQ Basic UDI-DI D-TSP004KQUDI-DIDate5 Jan 2023RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
TSP004
Model / Reference
TSP004
Primary DI / UDI-DI
D-TSP004KQ
Basic UDI-DI
B-TSP004KQ
EMDN Code
Z119080 Various bioimaging and radiotherapy instruments - hardware accessories
Device Class
Class I
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000027490
Authorised representative
Hoff & Lowendahl AB SE-AR-000001888

Other devices from Phantom Laboratory

See all devices from Phantom Laboratory →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No