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coDiagnostiX

by Dental Wings GmbH

Ref CDX-001-MD

coDiagnostiX (CDX-001-MD) is a device classified as Class IIa in the EU and Class II in the US made by Dental Wings GmbH, registered in EUDAMED on 6 May 2026 (Basic UDI-DI ++D835CODXDT), cleared under FDA 510(k) K193301 on 21 Jun 2021 and listed in FDA GUDID since 20 Jul 2021 (UDI-DI D835CODX1), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193301↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D835CODXDT Basic UDI-DI D835CODX1UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD835CODX1 UDI-DI Date20 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK193301 Date21 Jun 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++D835CODXDT registered 6 May 2026 Active
  • FDA 510(k) K193301 decided 21 Jun 2021 Active
  • FDA GUDID UDI-DI D835CODX1 listed 20 Jul 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193301
  2. Listed FDA GUDID D835CODX1
  3. Registered EUDAMED ++D835CODXDT

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Diagnostic x-ray digital imaging system workstation
Model / reference
CDX-001-MD EUDAMED
10 GUDID
Primary DI / UDI-DI
D835CODX1
Basic UDI-DI
++D835CODXDT
Direct marketing DI
D835CODX1
FDA product code
LLZ, DZJ
EMDN code
Z11069005 Diagnostic imaging workstations
GMDN term
Diagnostic x-ray digital imaging system workstation
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050, 872.4120
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CDX-001-MD
GUDID
10
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
DE-MF-000006867

Related devices

Category: Tissue specimen x-ray system IVD

Similar devices in this category

Other devices filed under DIAGNOSTIC IMAGING WORKSTATIONS.

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)