santecare Yes

GUDID 26953825909097

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 26953825909097
• NIH Device Record Key: fccbdcdb-a37f-4ac1-afe0-709cd39ef12f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: santecare
• Version Model Number: U83Y
• 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	06953825909093 [Primary]
GS1	26953825909097 [Package]; Contains: 06953825909093; Package: Carton [24 Units]; In Commercial Distribution

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: 2024-12-25
• Device Publish Date: 2024-12-17

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825909236 - COCACIS: 2025-01-09
• 16953825909168 - N/A: 2024-12-26
• 26953825909097 - santecare: 2024-12-25
• 26953825909097 - santecare: 2024-12-25
• 16953825909076 - Andesfit Health: 2024-12-13
• 16953825909083 - Tovendor: 2024-12-13
• 16953825909069 - N/A: 2024-12-10
• 16953825908994 - Aspire365: 2024-12-06
• 16953825908970 - Alphamed: 2024-12-02