MEDISANA

GUDID 06953825905057

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953825905057
• NIH Device Record Key: 72f19916-dcdb-4414-a307-2e4a4ca7c3a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDISANA
• Version Model Number: BU 510
• 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	06953825905057 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-09
• Device Publish Date: 2020-01-15

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825910607 - FOTOSY: 2025-11-25
• 16953825910614 - FOTOSY: 2025-11-25
• 16953825910546 - Tovendor: 2025-11-19
• 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