ASADAL-M1

GUDID 08800089800483

Huons Meditech Co., Ltd.

Electromechanical lithotripsy system, extracorporeal

• Primary Device ID: 08800089800483
• NIH Device Record Key: 255181de-ea6a-4e1a-a1e6-32710a140d28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASADAL-M1
• Version Model Number: ASADAL-M1
• Company DUNS: 695307449
• Company Name: Huons Meditech 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	08800089800483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131721

FDA Product Code

• LNS: Lithotriptor, Extracorporeal Shock-Wave, Urological

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: 2025-06-03
• Device Publish Date: 2025-05-26