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TytoCare

FDA UDI

Class U (US FDA UDI)

by Tyto Care Ltd

Identity

Trade Name
TytoCare FDA UDI
Generic Name
Multi-purpose digital medical camera FDA UDI
Device Name
The TytoCare 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 Ottoscope Intended use for Tyto Exam Camera: The Tyto Camera is an electronic camera that enables capturing and transmission of video and still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at one location on an IP network can view images and videos of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. Intended use for Tyto Basal Thermometer: The Tyto Basal Thermometer is an electronic thermometer that enables measuring basal body temperature as an aid in ovulation prediction to aid in conception (not to be used for contraception). In addition, the thermometer enables storage and transmitting the temperature measurement to a clinician on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. FDA UDI
Model / Reference
TytoCare FDA UDI
Description
The TytoCare 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 Ottoscope Intended use for Tyto Exam Camera: The Tyto Camera is an electronic camera that enables capturing and transmission of video and still images of throat (w / w/o tongue depressor) and skin, whereby a clinician at one location on an IP network can view images and videos of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. Intended use for Tyto Basal Thermometer: The Tyto Basal Thermometer is an electronic thermometer that enables measuring basal body temperature as an aid in ovulation prediction to aid in conception (not to be used for contraception). In addition, the thermometer enables storage and transmitting the temperature measurement to a clinician on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. FDA UDI

Identifiers

Catalog Number
800-00003 FDA UDI
Primary DI / UDI-DI
07290016672008 FDA UDI
FDA Product Code
LHD FDA UDI
KYT FDA UDI
GMDN Term
Multi-purpose digital medical camera FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
880.6350 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

No

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

Category: Infrared patient thermometer, skinMulti-purpose digital medical camera

TytoCare by Tyto Care Ltd — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose digital medical camera.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tyto Care Ltd

Sources (1)

  • FDA UDI e6fdc8ba-e21d-4567-81ca-c66e04e0ae54 35 fields · synced Jun 6, 2026