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Remex GR100

by Remedi Co., Ltd.

Remex GR100 is a hand-held intraoral dental x-ray system (FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by Remedi Co., Ltd., listed in FDA GUDID since 18 Apr 2025 (UDI-DI 08800060100205), registry data as of 21 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 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800060100205 UDI-DI Date18 Apr 2025ListedStatusListed 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  • Withdrawn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

Generic name
Hand-held intraoral dental x-ray system, digital
Model / reference
REMEX GR100
Primary DI / UDI-DI
08800060100205
FDA product code
EHD
GMDN term
Hand-held intraoral dental x-ray system, digital
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hand-held intraoral dental x-ray system, digital

Similar devices in this category

Other devices filed under Hand-held intraoral dental x-ray system, digital.

Other devices from Remedi Co., Ltd.

See all devices from Remedi Co., Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)