HARMONIZE

GUDID 06953825904937

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953825904937
• NIH Device Record Key: 4a18f239-b6e6-4f8d-ac1c-f1a5e47fb95e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARMONIZE
• Version Model Number: U80EH
• Company DUNS: 421294358
• Company Name: Shenzhen Urion Technology Co., Ltd
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953825904937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019
• Premarket Notification: K243115

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-09
• Device Publish Date: 2019-10-14

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825910959 - N/A: 2026-03-17
• 06953825910914 - medisana: 2026-03-11
• 16953825910904 - SDUNW: 2026-02-24
• 16953825910843 - N/A: 2026-02-16
• 16953825910850 - medisana: 2026-02-16
• 16953825910829 - SAKER: 2026-02-02
• 16953825910768 - AlphagoMed: 2026-01-14
• 16953825910607 - FOTOSY: 2025-11-25