Tympa Mobile App

GUDID 25060753520070

TYMPA HEALTH TECHNOLOGIES LIMITED

Video otoscope/audiometer
Primary Device ID25060753520070
NIH Device Record Key163992f5-937e-4630-a02e-fff70556ad35
Commercial Distribution StatusIn Commercial Distribution
Brand NameTympa Mobile App
Version Model NumberiOS
Company DUNS223449035
Company NameTYMPA HEALTH TECHNOLOGIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS125060753520070 [Primary]

FDA Product Code

ERAOtoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-12
Device Publish Date2025-02-04

Devices Manufactured by TYMPA HEALTH TECHNOLOGIES LIMITED

15060753520004 - Tympa Otoscope System2025-02-12
25060753520018 - Otoscope Assembly2025-02-12
25060753520025 - Otoscope Assembly Charging Stand2025-02-12
25060753520063 - Tympa Cloud2025-02-12
25060753520070 - Tympa Mobile App2025-02-12
25060753520070 - Tympa Mobile App2025-02-12

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