Myo Unit

GUDID 08057971592739

Device for displaying surface EMG signal intensity from active electrodes

BIONIT LABS SRL

Electromyograph

• Primary Device ID: 08057971592739
• NIH Device Record Key: 80ee65e9-1c2f-4836-9761-27c3248a7b2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myo Unit
• Version Model Number: MU01-01
• Company DUNS: 439080477
• Company Name: BIONIT LABS SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057971591053 [Primary]
GS1	08057971592739 [Package]; Contains: 08057971591053; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• HCJ: Device, Skin Potential Measurement

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: 2024-11-21
• Device Publish Date: 2024-11-13

Devices Manufactured by BIONIT LABS SRL

• 08057971594702 - Analog Amplifier with accessories: 2026-03-30 Analog Amplifier, 60 Hz with accessories - cable length 100 cm
• 08057971594795 - Remote Wave Electrode: 2026-03-30 Remote Wave Electrode, 60 Hz with accessories - cable length 30 cm
• 08057971594801 - Remote Wave Electrode: 2026-03-30 Remote Wave Electrode, 60 Hz with accessories - cable length 60 cm
• 08057971594818 - Remote Wave Electrode: 2026-03-30 Remote Wave Electrode, 60 Hz with accessories - cable length 100 cm
• 08057971594566 - Adam's Hand: 2025-12-25 Adam's Hand - Right, Small, Black, Short Wrist (device)
• 08057971593897 - Adam's Skin: 2025-12-10 Adam's Skin - Glove for Adam's Hand (spare part) - Basic Glove - Color: N1 - Side: Left - Size: Small
• 08057971593903 - Adam's Skin: 2025-12-10 Adam's Skin - Glove for Adam's Hand (spare part) - Basic Glove - Color: N1 - Side: Right- Size: Small
• 08057971595358 - MyoLogic: 2025-10-06 Software for configuring and customizing the Adam’s Hand device, designed for the end user