XEPA

GUDID 16953825906204

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16953825906204
• NIH Device Record Key: 8848dd12-da06-4988-bf71-b943c31bcd43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XEPA
• Version Model Number: U80R
• 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	06953825906207 [Primary]
GS1	16953825906204 [Package]; Contains: 06953825906207; Package: Carton [20 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: 2022-08-10
• Device Publish Date: 2022-08-02

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825909342 - EESLRNOE: 2025-02-21
• 16953825909304 - carda health: 2025-01-20
• 16953825909281 - VtsniMed: 2025-01-14
• 16953825909243 - EVOLUTI: 2025-01-13
• 16953825909236 - COCACIS: 2025-01-09
• 16953825909168 - N/A: 2024-12-26
• 26953825909097 - santecare: 2024-12-25
• 16953825909076 - Andesfit Health: 2024-12-13