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Drgem Topaz-40D

by DRGEM Corporation 2 variants

Ref TOPAZ-40DModel TOPAZ-32D, TOPAZ-40D

Drgem Topaz-40D is a device classified as Class IIb in the EU and Class II in the US made by DRGEM Corporation, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 88000111DM5000VU) and listed in FDA GUDID since 20 May 2019 (UDI-DI 08800011150020), 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 Number88000111DM5000VU Basic UDI-DI 08800011150020UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800011150020 UDI-DI Date20 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000111DM5000VU registered 20 May 2026 Active
  • FDA GUDID UDI-DI 08800011150020 listed 20 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800011150020
  2. Registered EUDAMED 88000111DM5000VU

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  • Withdrawn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
Topaz-40D EUDAMED
Drgem GUDID
Generic name
Mobile basic diagnostic x-ray system, digital
Device name
Mobile X-ray System
Model / reference
TOPAZ-40D, TOPAZ-32D
Primary DI / UDI-DI
08800011150020
Basic UDI-DI
88000111DM5000VU
FDA product code
IZL
EMDN code
Z11031101 Multifunctional systems for direct digital radiology
GMDN term
Mobile basic diagnostic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1720
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.

Related devices

Category: Mobile basic diagnostic x-ray system, digital

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)