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LungCT

by Gleamer 2 variants

Ref LungCT

LungCT is a medical device (EU MDR Class IIa) made by Gleamer Sas, registered in EUDAMED on 1 May 2025 (Basic UDI-DI 37700208390006L2), 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 Number37700208390006L2 Basic UDI-DI 03770020839184UDI-DIDate1 May 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
LungCT/BoneCT
Model / reference
LungCT
Primary DI / UDI-DI
03770020839184
Basic UDI-DI
37700208390006L2
EMDN code
Z11039082 Various radiodiagnostic and interventional instruments - software accessories
Device class
Class IIa
Special device type
Software
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
FR-MF-000011358

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES.

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Properties

Other properties (14, all answered No)