FDA.reportPublic FDA data

BubbleView

Primary DI
06975339621957
Brand
BubbleView
Company
MacroLux Medical Technology Co., Ltd.
Model
C50-CR
Device description
C50-CR Single-Use Digital Flexible Cystoscope
Published
2025-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975339621954PackageGS15In Commercial Distribution
26975339621951PackageGS12In Commercial Distribution
06975339621957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697533962195416975339621954
2697533962195126975339621951
06975339621957069753396219576975339621957

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, single-useA sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device.

Regulatory Flags#

DUNS number
723490133
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975339621179BubbleView®C50-C2024-07-10
06975339621186BubbleView®C50-CR2024-07-10
06975339621940BubbleView®C50-C2025-09-05
06975339623418SeleneView®HO422026-07-03
06975339628406Single-Use Biopsy ForcepsBF-S-1.6×3802026-07-03
06975339628413Single-Use Alligator GrasperGF-S-1.6×3802026-07-03
06975339628420Single-use Endoscopic ScissorsPS-S-1.6×3802026-07-03
06975339628512Single-Use Biopsy ForcepsBF-F-1.8×6002026-07-03
06975339628529Single-Use Biopsy ForcepsBF-F-1.8×600-G2026-07-03
06975339628536Single-Use Biopsy ForcepsBF-F-1.8×600-O2026-07-03
06975339628550Single-Use Grasping ForcepsGF-F-1.8×6002026-07-03
06975339628567Single-Use Grasping ForcepsGF-F-1.8×600-G2026-07-03
06975339628574Single-Use Grasping ForcepsGF-F-1.8×600-O2026-07-03
06975339628598Single-Use Biopsy ForcepsBF-S-1.6×380-G2026-07-03
06975339628604Single-Use Biopsy ForcepsBF-S-1.6×380-O2026-07-03
06975339628611Single-Use Alligator GrasperGF-S-1.6×380-G2026-07-03
06975339628628Single-Use Alligator GrasperGF-S-1.6×380-O2026-07-03
06975339628635Single-use Endoscopic ScissorsPS-S-1.6×380-G2026-07-03
06975339628642Single-use Endoscopic ScissorsPS-S-1.6×380-O2026-07-03
06975339620318CoralView®U10-B2024-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925602WiScope®Otu Medical Inc.FGB2026-07-28
00850023925619WiScope®Otu Medical Inc.FGB2026-07-28
00850023925626WiScope®Otu Medical Inc.FGB2026-07-28
00850023925633WiScope®Otu Medical Inc.FGB2026-07-28
00850023925640WiScope®Otu Medical Inc.FGB2026-07-28
00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140467WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140474WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140481WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28