Skip to content

Varex Digital Imaging Software, Nexus DR Nexus DR v4.x

by Varex Imaging Corporation

Ref v4.x

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00854344007801 UDI-DI Date29 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08543440070187 Basic UDI-DI 00854344007801UDI-DIDate19 Nov 2025RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Nexus DR EUDAMED
Varex Digital Imaging Software, Nexus DR GUDID
Generic Name
X-ray system computer, diagnostic, general-purpose
Device Name
Varex Nexus DR Digital X-ray Imaging System
Model / Reference
v4.x EUDAMED
Nexus DR v4.x GUDID
Primary DI / UDI-DI
00854344007801
Basic UDI-DI
08543440070187
Direct Marketing DI
00854344007801
510(k) Number
FDA Product Code
MQB
EMDN Code
Z11030592 Radiology instruments - medical device software
GMDN Term
X-ray system computer, diagnostic, general-purpose
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1680
Special Device Type
Software
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
v4.x
GUDID
Nexus DR v4.x
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Varex Imaging Corporation

See all devices from Varex Imaging Corporation →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No