Retone

GUDID 16974308960032

Xiamen Retone Hearing Technology Co., Ltd.

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 16974308960032
• NIH Device Record Key: b395c2a1-de0b-4113-a656-cfd1a1496eff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retone
• Version Model Number: Smart R 102BT
• Company DUNS: 544329913
• Company Name: Xiamen Retone Hearing Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	16974308960032 [Primary]

FDA Product Code

• QUF: Hearing Aid, Air-Conduction, Over The Counter

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: 2025-02-03
• Device Publish Date: 2025-01-24

On-Brand Devices [Retone ]

• 16974308960339: Smart U 1604
• 16974308960315: K219
• 16974308960308: Echo 1602RC-SF
• 16974308960292: Echo 403RC
• 16974308960285: Echo 402RC-T
• 16974308960254: Bro 402BT-RC
• 16974308960247: Bro 402RB-T
• 16974308960230: Bro 400RB-T
• 16974308960223: Bro 202
• 16974308960155: clear 102s
• 16974308960148: Vigor U 402BT-RC
• 16974308960131: Vigor U 402RC-T
• 16974308960124: K19B
• 16974308960117: K19RC
• 16974308960100: K19S
• 16974308960094: K239RC
• 16974308960087: K269RC
• 16974308960070: K259RB
• 16974308960063: K21
• 16974308960056: K20
• 16974308960049: K419-N
• 16974308960032: Smart R 102BT
• 16974308960025: Vigor 402BT-RC
• 16974308960018: Vigor 402RC-T
• 16974308960001: K216
• 06974308960288: clear 107H
• 06974308960271: Clear 102H
• 06974308960264: Clear 101H
• 06974308960257: clear 101 CIC
• 06974308960240: clear 101 ITC
• 06974308960233: clear 100 CIC
• 06974308960226: k18s
• 06974308960219: Bright 401P
• 06974308960202: Bright 601
• 06974308960196: Gio 402BT
• 06974308960189: Gio 402
• 06974308960172: Eggo 402BT
• 06974308960165: Eggo 402
• 06974308960158: Eggo 202
• 06974308960141: clear 400BT CIC
• 06974308960134: clear 100 ITC
• 06974308960127: Vigor U 403BT
• 06974308960110: Vigor U 403
• 06974308960103: Vigor U 402BT
• 06974308960097: Vigor U 402
• 06974308960080: Vigor 402BT-P
• 06974308960073: K218SP
• 06974308960066: Vigor 403BT
• 06974308960059: Vigor 403
• 06974308960042: Vigor 402BT