Empatica E4 E4

GUDID 00853858006324

EMPATICA SRL

Skin electrical conductance meter

• Primary Device ID: 00853858006324
• NIH Device Record Key: 15ab7314-8336-400c-98d1-4ed1067eff95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empatica E4
• Version Model Number: E4
• Catalog Number: E4
• Company DUNS: 430141750
• Company Name: EMPATICA 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: true
• Serial Number: true
• 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	00853858006324 [Primary]

FDA Product Code

• GZO: Device, Galvanic Skin Response 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: 2021-10-08
• Device Publish Date: 2021-09-30

Devices Manufactured by EMPATICA SRL

• 00853858006379 - EpiMonitor: 2024-08-22
• 00853858006386 - EpiMonitor: 2024-08-22
• 00853858006232 - Empatica Health Monitoring Platform: 2022-12-02
• 00853858006249 - Empatica Health Monitoring Platform: 2022-12-02
• 00853858006256 - Empatica Health Monitoring Platform: 2022-12-02
• 00853858006263 - Empatica Health Monitoring Platform: 2022-12-02
• 00853858006324 - Empatica E4: 2021-10-08
• 00853858006324 - Empatica E4: 2021-10-08
• 00853858006102 - Embrace2: 2020-02-19