Empatica Health Monitoring Platform EBP2-1G-SB-W

GUDID 00853858006546

EMPATICA SRL

Multiple vital physiological parameter monitoring system, home-use

• Primary Device ID: 00853858006546
• NIH Device Record Key: 4e61c7bf-e8b9-47d7-bcfa-dff62464f886
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empatica Health Monitoring Platform
• Version Model Number: EmbracePlus2 Silicone Band - White
• Catalog Number: EBP2-1G-SB-W
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853858006546 [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: 2026-02-24
• Device Publish Date: 2026-02-16

On-Brand Devices [Empatica Health Monitoring Platform]

• 00853858006263: Care Portal
• 00853858006256: Care App Android Version
• 00853858006249: Care App iOS
• 00853858006232: EmbracePlus
• 00853858006751: EmbracePlus2 with Elastic Strap
• 00853858006546: EmbracePlus2 Silicone Band - White