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Instrumentation Difra

FDA UDI

Class I (US FDA UDI)

by Instrumentation Difra SA

Identity

Trade Name
Instrumentation Difra FDA UDI
Generic Name
Diagnostic caloric vestibular stimulation system FDA UDI
Device Name
The water caloric stimulator is a device that delivers a stream of water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produces involuntary eye movements. An internal chronometer offers through a second rotary switch the possibility to select the stimulation time. Five stimulation times are available: 20, 30, 40,50 and 60s By default, temperature values are 27°C, 30°C, 37°C and 44°C. Minimal temperature reachable: 3°C over the ambient temperature Maximal temperature reachable: 48°C Water flow: fixed, 350ml/min Timer Requires a water supply and an outlet Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process. FDA UDI
Model / Reference
AquaStar 115V 2.0 FDA UDI
Description
The water caloric stimulator is a device that delivers a stream of water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produces involuntary eye movements. An internal chronometer offers through a second rotary switch the possibility to select the stimulation time. Five stimulation times are available: 20, 30, 40,50 and 60s By default, temperature values are 27°C, 30°C, 37°C and 44°C. Minimal temperature reachable: 3°C over the ambient temperature Maximal temperature reachable: 48°C Water flow: fixed, 350ml/min Timer Requires a water supply and an outlet Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process. FDA UDI

Identifiers

Catalog Number
17550 FDA UDI
Primary DI / UDI-DI
B516175500 FDA UDI
FDA Product Code
ETP FDA UDI
GMDN Term
Diagnostic caloric vestibular stimulation system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.1800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 11.5 Centimeter FDA UDI
Depth — 35.5 Centimeter FDA UDI
Length — 31 Centimeter FDA UDI
Weight — 5 Kilogram FDA UDI

Category: Diagnostic caloric vestibular stimulation system

Instrumentation Difra by Instrumentation Difra SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic caloric vestibular stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instrumentation Difra SA

Sources (1)

  • FDA UDI 8f232aa0-c953-40bf-aa3a-3ed4e509c5d7 37 fields · synced May 30, 2026