Medisana, Blood pressure monitor

GUDID 06948158401246

SHENZHEN COMBEI TECHNOLOGY CO.,LTD

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06948158401246
• NIH Device Record Key: 46121b06-95c1-484e-8070-5ffe3ed06606
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medisana, Blood pressure monitor
• Version Model Number: BU 600
• Company DUNS: 529383632
• Company Name: SHENZHEN COMBEI 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948158401246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181104

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: 2026-01-29
• Device Publish Date: 2026-01-21

Devices Manufactured by SHENZHEN COMBEI TECHNOLOGY CO.,LTD

• 06948158401246 - Medisana, Blood pressure monitor: 2026-01-29
• 06948158401246 - Medisana, Blood pressure monitor: 2026-01-29
• 06948158401499 - YBWM: 2020-08-20
• 06948158404469 - HOMIEE: 2019-11-08
• 06948158404452 - HOMIEE: 2019-11-08
• 06948158403905 - Homiee: 2019-11-08
• 06948158403912 - Homiee: 2019-11-08
• 06948158403929 - Hylogy: 2019-11-08
• 06948158403936 - Homiee: 2019-11-08