Echolight S.p.a.

GUDID 08052461860022

ECHOLIGHT SPA

Bioelectrical body composition analyser

• Primary Device ID: 08052461860022
• NIH Device Record Key: a05f5c61-36ca-404a-943f-2a62a79742a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echolight S.p.a.
• Version Model Number: EchoS
• Company DUNS: 431139071
• Company Name: ECHOLIGHT SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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	08052461860008 [Previous]
GS1	08052461860022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202514

FDA Product Code

• MUA: Bone Sonometer

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: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [Echolight S.p.a.]

• 08052461860039: EchoStation
• 08052461860022: EchoS
• 08052461860046: EchoStudio