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Apixia Digirex 108US

by Dentamerica

Apixia Digirex 108US is a Class II device made by Dentamerica, listed in FDA GUDID since 21 Apr 2026 (UDI-DI 00850461008042), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850461008042 UDI-DI Date21 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Apixia Digirex
Generic name
Flat panel x-ray detector integration unit
Model / reference
108US
Primary DI / UDI-DI
00850461008042
FDA product code
MUH
GMDN term
Flat panel x-ray detector integration unit
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MUH (System, X-Ray, Extraoral Source, Digital).

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Properties

Other properties (15, all answered No)