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Drgem Dxc-Rml

by DRGEM Corporation

Ref DXC-RMLModel DXC-RML, DXC-RMH

Drgem Dxc-Rml is a medical device (EU MDR Class IIb; FDA Class II; FDA product code IZX, Collimator, Manual, Radiographic) made by DRGEM Corporation, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 88000111BLD0400TM) and listed in FDA GUDID since 24 Jul 2018 (UDI-DI 08800011104016), 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 Number88000111BLD0400TM Basic UDI-DI 08800011104016UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800011104016 UDI-DI Date24 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000111BLD0400TM registered 28 May 2026 Active
  • FDA GUDID UDI-DI 08800011104016 listed 24 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800011104016
  2. Registered EUDAMED 88000111BLD0400TM

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  • Withdrawn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
Dxc-Rml EUDAMED
Drgem GUDID
Generic name
Manual-aperture-control diagnostic x-ray system collimator, non-motorized
Device name
X-ray collimator
Model / reference
DXC-RML, DXC-RMH
Primary DI / UDI-DI
08800011104016
Basic UDI-DI
88000111BLD0400TM
FDA product code
IZX
EMDN code
Z11039080 Various radiodiagnostic and interventional instruments - hardware accessories
GMDN term
Manual-aperture-control diagnostic x-ray system collimator, non-motorized
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1610
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: Manual-aperture-control diagnostic x-ray system collimator, non-motorized

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from DRGEM Corporation

See all devices from DRGEM Corporation →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)