Mamba Vision

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: MAMBA VISION FDA UDI
Generic Name: Flexible video cystoscope, reusable FDA UDI
Device Name: SENSOR-CYSTOSCOPE 16.2FR WL 400MM flexible, working channel 7,5FR, slanted distal tip, TL 660mm, deflection +210°/-210°, two function buttons, control lever to distal – downward DEF, for connection to ENDOCAM Logic HD and ENDOCAM Logic HD lite 5525, LED-illumination, distal Sensor, Fixfocus FDA UDI
Model / Reference: 7315001US FDA UDI
Description: SENSOR-CYSTOSCOPE 16.2FR WL 400MM flexible, working channel 7,5FR, slanted distal tip, TL 660mm, deflection +210°/-210°, two function buttons, control lever to distal – downward DEF, for connection to ENDOCAM Logic HD and ENDOCAM Logic HD lite 5525, LED-illumination, distal Sensor, Fixfocus FDA UDI

Identifiers

Catalog Number: 7315001US FDA UDI
Primary DI / UDI-DI: 04055207065518 FDA UDI
FDA Product Code: FAJ FDA UDI
GMDN Term: Flexible video cystoscope, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Hydrogen Peroxide FDA UDI

Dimensions & Sizes

Size: Length — 400 Millimeter FDA UDI

Category: Flexible video cystoscope, reusable

Mamba Vision by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video cystoscope, reusable.

HD-VIEW — Karl Storz GmbH & Co. KG · Class II
Flexible Video Cystoscope (NTSC) — COGENTIX MEDICAL, INC. · Class II
Flexible Video Cystoscope (NTSC) Intuitive — COGENTIX MEDICAL, INC. · Class II
LUMINELLE DTx Hysteroscopy System — Uvision360, Inc. · Class II
C-VIEW — Karl Storz GmbH & Co. KG · Class II
DirectVision — Percuvision, LLC · Class II
VIDEO CYTOSCOPE — PENTAX of America, Inc. · Class II
Luminelle DTx Control Hub — Uvision360, Inc. · Class II

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: Richard Wolf GmbH

Sources (1)

FDA UDI 9ea1e4ba-6351-42c7-98a6-b65f06dd5bcb 36 fields · synced May 30, 2026