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Diamond-8A

by DRGEM Corporation

Ref DIAMOND-8AModel DIAMOND-5A, DIAMOND-6A, DIAMOND-8A

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000111DSDIA4000GM Basic UDI-DI 08800011140915UDI-DIDate21 May 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  • Withdrawn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
Digital diagnostic X-ray System
Model / Reference
DIAMOND-5A, DIAMOND-6A, DIAMOND-8A
Primary DI / UDI-DI
08800011140915
Basic UDI-DI
88000111DSDIA4000GM
EMDN Code
Z11031101 Multifunctional systems for direct digital radiology
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