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Dxt-8M

by DRGEM Corporation

Ref DXT-8MModel DXT-8M, DXT-10M, DXT-11M, DXT-12M, DXT-14U, DXT-15U

Active European Union

CE MDR

Valid until

Not listed

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

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/MDR Number88000111XT050086 Basic UDI-DI 08800011105006UDI-DIDate2 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Rotating Anode X-ray Tube Assembly
Model / Reference
DXT-8M, DXT-10M, DXT-11M, DXT-12M, DXT-14U, DXT-15U
Primary DI / UDI-DI
08800011105006
Basic UDI-DI
88000111XT050086
EMDN Code
Z11039012 X-ray tube assembly
Device Class
Class IIb
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000017990
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from DRGEM Corporation

See all devices from DRGEM Corporation →

Properties

Other properties (13)

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