Tympa Otoscope System iPhone 13

by Tympa Health Technologies Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05060753520090 UDI-DI	Date19 Nov 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Tympa Otoscope System
Generic Name: Video otoscope/audiometer
Model / Reference: iPhone 13

Primary DI / UDI-DI: 05060753520090
FDA Product Code: ERA, EWO
GMDN Term: Video otoscope/audiometer

Device Class: Class I
Regulation Number: 874.4770, 874.1050
GUDID distribution status: In Commercial Distribution

Other devices from Tympa Health Technologies Inc

Otoscope Assembly Charging Stand iPhone 13

Class I
Otoscope Assembly iPhone 13

Class I

Properties

Prescription Use
Convenience Kit
Premarket Exempt
Lot / Batch Number
Serial Number
Manufacturing Date

Other properties (8)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Combination Product: No
HCT/P: No
Expiration Date: No