Identity
- Trade Name
- BubbleView® FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CBR FDA UDI
- Model / Reference
- C50-CBR FDA UDI
- Description
- BubbleView®, Single-Use Digital Flexible Cystoscope, C50-CBR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975339621209 FDA UDI
- 510(k) Number
- K240283 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Flexible video cystoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Flexible video cystoscope, single-use
BubbleView® by MacroLux Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video cystoscope, single-use.
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- VersaVue Tablet - Global/CE Demo — MEDIMAGING INTEGRATED SOLUTION INC. · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Prosurg — Prosurg, Inc · Class II
- Aptra — OTU MEDICAL INC. · Class II
- Prosurg — Prosurg, Inc · Class II
Cleared under the same submission
K240283 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MacroLux Medical Technology Co., Ltd.
Sources (1)
- FDA UDI 92280cf2-021f-46b2-b076-e4da091ffeac 34 fields · synced Jun 8, 2026