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BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-…

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K240283Ref Power adapterModel S13, S13-T, S13-N, S13-SRef Trolley of Video ProcessorRef C50-CModel C38-CS/ C38-CRS/ C50-C/ C50-CR/ C50-CB/ C50-CBRRef C38-CSRef Mounting holder for VESA holder

by MacroLux Medical Technology Co., Ltd.

Identity

Trade Name
BubbleView EUDAMED
Power adapter FDA UDI
BubbleView® FDA UDI
Mounting Holder FDA UDI
Generic Name
Endoscopic video image processing unit FDA UDI
Flexible video cystoscope, single-use FDA UDI
Device Name
Video Processor EUDAMED
Single-Use Digital Flexible Cystoscope EUDAMED
BubbleView®, Single-Use Digital Flexible Cystoscope, C50-C FDA UDI
Mounting Holder FDA UDI
C50-C Single-Use Digital Flexible Cystoscope 6.6/14.4Fr,Standard,U235°/D145° FDA UDI
Model / Reference
C50-C EUDAMEDFDA UDI
S13, S13-T, S13-N, S13-S EUDAMED
Power adapter EUDAMED
Trolley of Video Processor EUDAMED
C38-CS/ C38-CRS/ C50-C/ C50-CR/ C50-CB/ C50-CBR EUDAMED
C38-CS EUDAMED
Mounting holder for VESA holder EUDAMED
Type B (Japan) FDA UDI
Type I FDA UDI
for VESA holder FDA UDI
Type L FDA UDI
Type B (USA) FDA UDI
Type G FDA UDI
Type N FDA UDI
Description
BubbleView®, Single-Use Digital Flexible Cystoscope, C50-C FDA UDI
Mounting Holder FDA UDI
C50-C Single-Use Digital Flexible Cystoscope 6.6/14.4Fr,Standard,U235°/D145° FDA UDI

Identifiers

Primary DI / UDI-DI
06975339626754 EUDAMEDFDA UDI
06975339626761 EUDAMEDFDA UDI
06975339621179 EUDAMEDFDA UDI
06975339626631 EUDAMEDFDA UDI
06975339626747 EUDAMEDFDA UDI
06975339626723 EUDAMEDFDA UDI
06975339621940 EUDAMEDFDA UDI
06975339626716 EUDAMEDFDA UDI
06975339626778 EUDAMEDFDA UDI
06975339626785 EUDAMED
06975339626495 EUDAMED
06975339626730 EUDAMED
06975339621926 EUDAMED
06975339621506 EUDAMED
Basic UDI-DI
697533962002ML EUDAMED
697533962004MQ EUDAMED
510(k) Number
K240283 FDA 510(k)FDA UDI
FDA Product Code
FAJ FDA 510(k)FDA UDI
EOQ FDA UDI
EMDN Code
Z12020406 VIDEO PROCESSORS EUDAMED
Z12020701 CYSTOSCOPES EUDAMED
GMDN Term
Endoscopic video image processing unit FDA UDI
Flexible video cystoscope, single-use FDA UDI
Models / Variants
BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR) FDA 510(k)FDA UDIEUDAMED
ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class I EUDAMED
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)FDA UDI
874.4680 FDA UDI
Market of Registration
France EUDAMED
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

No

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDIFDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI
MRI Safety
MR Unsafe FDA UDI

The BubbleView Single-Use Digital Flexible Cystoscope is a flexible endoscope designed for visual examination of the bladder and lower urinary tract. It combines digital imaging technology with a single-use, sterile design to provide real-time visualization of internal structures, aiding in diagnostic and procedural assessments in urology and gastroenterology.

This device is supplied as a single-use, sterile system comprising the cystoscope and a compatible ViewHub Video Processor for image capture and display. The cystoscopes (C50-C, C50-CR, C50-CB, C50-CBR) are intended for use in clinical settings, including operating rooms and examination rooms, and are regulated under FDA 510K and MDR frameworks. The device is classified as Class II and includes multiple model-specific FEI numbers for regulatory tracking.

Frequently asked questions

What clinical specialties is the BubbleView Single-Use Digital Flexible Cystoscope primarily intended for use in, and why?

The BubbleView Single-Use Digital Flexible Cystoscope is primarily intended for use in urology and gastroenterology, as explicitly noted in the medical specialty description. This is because the device is designed for visual examination of the bladder and lower urinary tract, which directly aligns with urological procedures, while its flexible design and imaging capabilities also support diagnostic assessments in gastroenterology for related lower tract evaluations.

Is the BubbleView system single-use, and if so, how does this impact its clinical workflow?

Yes, the BubbleView Single-Use Digital Flexible Cystoscope is explicitly designed for single-use only, ensuring sterility and eliminating the need for reprocessing. This simplifies clinical workflows by reducing contamination risks, lowering maintenance requirements, and streamlining setup and disposal processes in operating rooms or examination rooms.

What components make up the BubbleView system, and how are they paired for use?

The BubbleView system consists of four single-use cystoscope models (C50-C, C50-CR, C50-CB, C50-CBR) paired with one of four ViewHub® Video Processor models (S13, S13-T, S13-N, S13-S). The cystoscope is the disposable, sterile insertion device, while the ViewHub processor captures and displays real-time digital images, enabling diagnostic visualization during procedures.

Are there different sizes or models of the BubbleView cystoscope, and what distinguishes them?

Yes, the BubbleView system includes four distinct cystoscope models (C50-C, C50-CR, C50-CB, C50-CBR), each likely differentiated by features like channel configuration (e.g., irrigation capabilities) or working length. While the exact specifications aren’t detailed, the inclusion of multiple FEI numbers suggests regulatory tracking for variations in design or functionality, which may cater to specific clinical needs (e.g., pediatric vs. adult use).

How should the BubbleView system be stored, and what precautions should be taken?

The BubbleView Single-Use Digital Flexible Cystoscope is supplied sterile, so storage should follow standard single-use medical device protocols to maintain integrity. This includes keeping the system in its original, sealed packaging until use, protecting it from physical damage, extreme temperatures, or contamination. The ViewHub processor, being reusable, should be stored in a clean, dry environment per manufacturer guidelines to ensure optimal performance and longevity.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
MacroLux Medical Technology Co., Ltd.

Sources (24)

  • FDA 510(k) K240283 24 fields · synced Sep 18, 2026
  • FDA UDI 1fd759e1-211f-462e-9abb-7e9db388e0ef 32 fields · synced May 24, 2026
  • FDA UDI ec7d9b11-163e-4d30-93f7-fe28eb08bdd8 32 fields · synced May 29, 2026
  • FDA UDI 47fb2c82-f5c3-49e7-801a-c7b1a019a7c3 34 fields · synced May 30, 2026
  • FDA UDI 9ccad3eb-47ca-4a17-8b9e-d0e25d8cde2f 33 fields · synced May 30, 2026
  • FDA UDI 6fd53aee-5daf-472f-b59c-367b402b4dda 32 fields · synced May 30, 2026
  • FDA UDI 12e70bd7-8e0d-4cff-9091-01b17ab43695 32 fields · synced May 30, 2026
  • FDA UDI 0c8fba4c-b632-4df0-8cfa-532443ccae0a 33 fields · synced May 30, 2026
  • FDA UDI 27cb3f99-e742-4236-82bf-d5b6a162cea7 32 fields · synced May 30, 2026
  • FDA UDI 0fdf1190-3d62-4738-8904-b7552355f63a 32 fields · synced May 30, 2026
  • EUDAMED 01e8ec99-56a2-4a91-b509-313ca40e8d04 61 fields · synced Jun 20, 2026
  • EUDAMED 0a0b36a0-52a6-4fd5-986d-4a83ed846674 61 fields · synced Jul 8, 2026
  • EUDAMED 8e5864c6-e6fb-47bf-ab5a-b3e45efb4202 61 fields · synced Jul 10, 2026
  • EUDAMED 4b0f7ae0-5814-4a9d-ad65-f8279df4b093 61 fields · synced Jul 10, 2026
  • EUDAMED 92923f51-fe8f-45bc-baa1-3838c5fbec0a 61 fields · synced Jul 10, 2026
  • EUDAMED d59319ef-f5bc-479e-b265-cd37d4b1096d 61 fields · synced Jul 19, 2026
  • EUDAMED a913adbe-a6eb-4654-85ce-d5b9f90a1926 61 fields · synced Jul 21, 2026
  • EUDAMED 84f01713-e821-4c9e-abed-71691bec4129 61 fields · synced Jul 22, 2026
  • EUDAMED 55e23bcb-d7d0-4749-b235-9028777e8092 61 fields · synced Jul 24, 2026
  • EUDAMED b1e989cf-66b5-4d81-bb98-d5d8e5e36e53 61 fields · synced Jul 26, 2026
  • EUDAMED c6a2529f-d288-44ce-8c43-e3b51627d08a 61 fields · synced Jul 27, 2026
  • EUDAMED f3b4a7e2-f9ae-4989-9524-c48b3d65d123 61 fields · synced Jul 27, 2026
  • EUDAMED 49d5a625-a321-48d5-a7dc-65dbfd8ef571 61 fields · synced Jul 30, 2026
  • EUDAMED cdb3ae22-3592-46c1-a3b9-1219ce504528 61 fields · synced Sep 18, 2026