Thermidas ThIRT-384

GUDID 06429810718037

Thermidas IRT-384 Tablet is a handheld thermal imaging system for measuring and monitoring changes in skin surface temperature non-invasively. The tablet-based solution allows simultaneous capture of both thermal and visual spectrum images. With its built-in software the all-in-one solution supports capture, analysis and long-term storage the image data with minimum effort.

TherMidas Oy

Infrared thermography system

• Primary Device ID: 06429810718037
• NIH Device Record Key: 0dfcbd0c-ba00-4230-8541-07394f054e8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermidas
• Version Model Number: Thermidas IRT-384 Tablet
• Catalog Number: ThIRT-384
• Company DUNS: 540505042
• Company Name: TherMidas Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi

Device Identifiers

Device Issuing Agency	Device ID
GS1	06429810718037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200999

FDA Product Code

• LHQ: System, Telethermographic (Adjunctive Use)

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: 2025-04-16
• Device Publish Date: 2025-04-08

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