hysure Yes

GUDID 16953825906228

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16953825906228
• NIH Device Record Key: 87c6835d-ba53-41f1-ae07-631312b8324e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hysure
• Version Model Number: U82W
• Catalog Number: Yes
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953825906221 [Primary]
GS1	16953825906228 [Package]; Contains: 06953825906221; Package: Carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-24
• Device Publish Date: 2022-08-16

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825901070 - AlphaMed: 2025-09-08
• 16953825910041 - Alphamed: 2025-08-08
• 16953825909960 - N/A: 2025-07-10
• 16953825909953 - N/A: 2025-07-09
• 16953825909939 - Dr. Aid: 2025-07-07
• 16953825909892 - AlphaMed: 2025-06-30
• 16953825909878 - CuPiLO: 2025-06-23
• 16953825909885 - AlphaMed: 2025-06-23