QbCheck

GUDID 07350103930012

Qbtech AB

Psychological assessment software

• Primary Device ID: 07350103930012
• NIH Device Record Key: 40f60cf3-a80a-43be-a22f-a7dd7fc73f9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QbCheck
• Version Model Number: 001
• Company DUNS: 508374720
• Company Name: Qbtech AB
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350103930012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143468

FDA Product Code

• LQD: Recorder, Attention Task Performance

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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by Qbtech AB

• 07350103930012 - QbCheck: 2023-06-22
• 07350103930012 - QbCheck: 2023-06-22
• 07350103930067 - QbTest: 2023-06-22