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Drgem Diamond-6A

by DRGEM Corporation

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

Drgem Diamond-6A is a device classified as Class IIb in the EU and Class II in the US made by DRGEM Corporation, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 88000111DSDIA4000GM) and listed in FDA GUDID since 29 May 2017 (UDI-DI 08800011140168), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000111DSDIA4000GM Basic UDI-DI Date21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800011140168 UDI-DI Date29 May 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000111DSDIA4000GM registered 21 May 2026 Active
  • FDA GUDID UDI-DI 08800011140168 listed 29 May 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800011140168
  2. Registered EUDAMED 88000111DSDIA4000GM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Diamond-6A EUDAMED
Drgem GUDID
Generic name
Stationary basic diagnostic x-ray system, digital
Device name
Digital diagnostic X-ray System
Model / reference
DIAMOND-6A, DIAMOND-5A, DIAMOND-8A
Description
*Line power rating: 480V3~ *MAX Tube voltage: 150kV
*Line power rating: 400V3~ *MAX Tube voltage: 150kV
Primary DI / UDI-DI
08800011140168, 08800011140014
Basic UDI-DI
88000111DSDIA4000GM
FDA product code
KPR
EMDN code
Z11031101 Multifunctional systems for direct digital radiology
GMDN term
Stationary basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1680
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY.

Other devices from DRGEM Corporation

See all devices from DRGEM Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)