SAKER

GUDID 16953825910829

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16953825910829
• NIH Device Record Key: a5279357-707e-4453-93ea-1105d432ac55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAKER
• Version Model Number: U90B
• Company DUNS: 421294358
• Company Name: Shenzhen Urion Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	06953825910822 [Primary]
GS1	16953825910829 [Package]; Contains: 06953825910822; Package: Carton [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241007

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: 2026-02-02
• Device Publish Date: 2026-01-23

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

• 16953825910829 - SAKER: 2026-02-02
• 16953825910829 - SAKER: 2026-02-02
• 16953825910768 - AlphagoMed: 2026-01-14
• 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