Empatica EBP2-1G-FB-B

GUDID 00853858006584

EMPATICA SRL

Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 00853858006584
• NIH Device Record Key: 10330c92-ddd8-428e-aab2-45092e18bcf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empatica
• Version Model Number: EmbracePlus2 Stretchable Band - Black
• Catalog Number: EBP2-1G-FB-B
• Company DUNS: 430141750
• Company Name: EMPATICA SRL
• 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: 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	00853858006584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230457

FDA Product Code

• DQA: Oximeter

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: 2025-07-04
• Device Publish Date: 2025-06-26

Devices Manufactured by EMPATICA SRL

• 00853858006584 - Empatica: 2025-07-04
• 00853858006584 - Empatica: 2025-07-04
• 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