Medivision

FDA UDI

Class II (US FDA UDI)

by Medivision, Inc.

Identity

Trade Name: MEDIVISION FDA UDI
Generic Name: Rigid optical hysteroscope FDA UDI
Device Name: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. HYSTEROSCOPE MediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. FDA UDI
Model / Reference: MV400 FDA UDI
Description: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. HYSTEROSCOPE MediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. FDA UDI

Identifiers

Catalog Number: MV400 FDA UDI
Primary DI / UDI-DI: 00851328007192 FDA UDI
FDA Product Code: HIH FDA UDI
FAJ FDA UDI
GMDN Term: Rigid optical hysteroscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1690 FDA UDI
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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Rigid optical cystoscope Rigid optical hysteroscope

Medivision by Medivision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical hysteroscope.

TruClear — Covidien LP · Class II
BR Surgical, LLC — BR SURGICAL LLC · Class II
TRUCLEAR — Smith & Nephew, Inc. · Class II
MyoSure XL Rod Lens Hysteroscope — Hologic, Inc. · Class II
Hysteroscope — SOPRO-COMEG GmbH · Class II
HOPKINS — Karl Storz GmbH & Co. KG · Class II
Gimmi — Gimmi GmbH · Class II
HOPKINS — Karl Storz GmbH & Co. KG · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medivision, Inc.

Sources (1)

FDA UDI 00a1fbd6-2c4d-4453-b27c-f06106ce3ce9 34 fields · synced May 30, 2026