BubbleView®

GUDID 16975339621947

C50-C Single-Use Digital Flexible Cystoscope 6.6/14.4Fr,Standard,U235°/D145°

MacroLux Medical Technology Co., Ltd.

Flexible video cystoscope, single-use

• Primary Device ID: 16975339621947
• NIH Device Record Key: 0c8fba4c-b632-4df0-8cfa-532443ccae0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BubbleView®
• Version Model Number: C50-C
• Company DUNS: 723490133
• Company Name: MacroLux Medical 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975339621940 [Primary]
GS1	16975339621947 [Package]; Contains: 06975339621940; Package: [5 Units]; In Commercial Distribution
GS1	26975339621944 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-15
• Device Publish Date: 2025-09-05

On-Brand Devices [BubbleView®]

• 16975339621206: BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CBR
• 16975339621190: BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CB
• 16975339621183: BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CR
• 16975339621176: BubbleView®, Single-Use Digital Flexible Cystoscope, C50-C
• 16975339621947: C50-C Single-Use Digital Flexible Cystoscope 6.6/14.4Fr,Standard,U235°/D145°