GUDIDData
gudid Primary ID: Tyto Device

Tyto Device (UDI Tyto Device)

Manufactured by TYTO CARE LTD

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Tyto Device - Primary ID Tyto Device

Device Regulatory Overview

The Tyto Device (Model/Catalog Number: Tyto Device) is a medical device manufactured by TYTO CARE LTD. This product is indexed under FDA Product Code / Category Classification KYT within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Tyto Device
Product Code / EMDN
KYT
Device Name
The Tyto Device unit contains the Tyto Exam Camera and Tyto Basal Thermometer. It is used also as the display (UI) and operation component of other TytoPro kit components: the Tyto Stethoscope and Tyto OttoscopeIntended use for Tyto Exam Camera:The Tyto Camera is an electronic camera that enables capturing and transmission of videoand still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at onelocation on an IP network can view images and videos of a patient on site or at a differentlocation on the IP network with the signal carried on an IP connection between the twolocations.Intended use for Tyto Basal Thermometer:The Tyto Basal Thermometer is an electronic thermometer that enables measuring basalbody temperature as an aid in ovulation prediction to aid in conception (not to be usedfor contraception). In addition, the thermometer enables storage and transmitting thetemperature measurement to a clinician on site or at a different location on the IP networkwith the signal carried on an IP connection between the two locations.
Database Sync Date
2026-08-09 09:18:18

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Tyto Device?

The registered manufacturer of record for Tyto Device is TYTO CARE LTD.

What is the Primary UDI-DI identifier for Tyto Device?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Tyto Device.

What classification code is assigned to this device?

This device is registered under product classification code KYT.

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