REMEX GR100

GUDID 08800060100205

REMEDI CO.,LTD.

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 08800060100205
• NIH Device Record Key: a92dd004-75b8-42c4-82a6-878a97161865
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REMEX GR100
• Version Model Number: REMEX GR100
• Company DUNS: 690072489
• Company Name: REMEDI CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800060100205 [Primary]

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-28
• Device Publish Date: 2025-04-18

Devices Manufactured by REMEDI CO.,LTD.

• 08800060100205 - REMEX GR100: 2025-04-28
• 08800060100205 - REMEX GR100: 2025-04-28
• 08800060100243 - ENDURO DR: 2024-09-30
• 08800060100236 - ENDORO DR ES70 X-ray Source: 2024-07-31
• 08800060100151 - REMEX KA6: 2022-04-21