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Drgem Jade-32

by DRGEM Corporation

Ref JADE-32Model JADE-32, JADE-40

Drgem Jade-32 is a mobile basic diagnostic x-ray system (EU MDR Class IIb; FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by DRGEM Corporation, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 88000111AM5000UM), cleared under FDA 510(k) K183388 on 5 Feb 2019 and listed in FDA GUDID since 11 Feb 2019 (UDI-DI 08800011150082), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183388

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000111AM5000UM Basic UDI-DI 08800011150082UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800011150082 UDI-DI Date11 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183388 Date5 Feb 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000111AM5000UM registered 20 May 2026 Active
  • FDA 510(k) K183388 decided 5 Feb 2019 Active
  • FDA GUDID UDI-DI 08800011150082 listed 11 Feb 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183388
  2. Listed FDA GUDID 08800011150082
  3. Registered EUDAMED 88000111AM5000UM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Jade-32 EUDAMED
Drgem GUDID
Generic name
Mobile basic diagnostic x-ray system, analogue
Device name
Mobile X-ray System
Model / reference
JADE-32, JADE-40
Description
100~240V~ 120kV
Primary DI / UDI-DI
08800011150082
Basic UDI-DI
88000111AM5000UM
510(k) Number
FDA product code
IZL
EMDN code
Z110310 Multifunctional systems for traditional radiology
GMDN term
Mobile basic diagnostic x-ray system, analogue
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, analogue

Cleared under the same submission (K183388)

Similar devices

Also classified as Mobile basic diagnostic x-ray system, analogue.

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL 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)