Home GUDID 00860003469828 hearX
Primary DI 00860003469828
Brand hearX
Company HEARX GROUP (PTY) LTD
Model hearScope
Device description hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).
Published 2022-05-30
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name ERA Otoscope
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ERA Otoscope Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860003469828 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860003469828 00860003469828 860003469828 0860003469828
GMDN Terms# Term, Definition table Term Definition Otoscope, direct An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.
Sterilization Methods# Method table Method High-level Disinfectant
Regulatory Flags# DUNS number 539177681 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810153660323 Lexie B3 Hearing Aids Lexie Hearing LBS00001B3 2026-05-07 00810153660408 Lexie H1 Powered by Bose Lexie Hearing LBS00001H1 2025-10-01 00810153660828 Lexie H1 OTC Hearing Buds Lexie Hearing LBS00002H1 2025-10-01 00810153660811 Lexie Hearing Lexie B2 Powered by Bose (AARP Bundle) LBS00001B2UF 2025-07-31 00850022464621 hearX Group hearOAE 2025-03-04 00810153660217 Go Prime - Black Go Hearing GHPA00003BE 2024-08-19 00810153660187 Go Prime - Beige Go Hearing GHPS00003BE 2024-05-17 00850022464591 Go Prime - Beige Go Hearing 2024-02-12 00810153660149 Lexie Hearing Refurbished Lexie B1 Powered by Bose R-LBS00001B1 2024-03-07 00810153660156 Lexie Hearing Refurbished Lexie B2 Powered by Bose R-LBS00001B2 2024-03-07 00810153660163 Lexie Hearing Refurbished Lexie B2 Plus Powered by Bose R-LBS00001B2PLS 2024-03-07 00850022464973 Lexie B2 Plus Powered by Bose Lexie Hearing LBS00001B2PLS 2024-01-31 00810153660057 Go Hearing Go Ultra - Gray - BTE - WAG Online 2024-01-15 10810153660054 Go Hearing Go Ultra - Gray - BTE - WAG Online - CASE GHUS00002CA 2024-01-15 00810153660033 Lexie B2 Plus Powered by Bose Lexie Hearing LBS00002B2PLS 2024-01-08 00810153660040 Go Prime Go Hearing GHPS00003BL 2023-12-18 00850022464256 Lexie Hearing Lexie Android App Lexie Android App 2022-04-13 00850022464263 Lexie Hearing Lexie iOS App Lexie iOS App 2022-04-13 00850022464942 Lexie Hearing Lexie B2 Self-fitting OTC Hearing Aids, Powered by 2023-02-06 00850022464638 Lexie B2, Powered by Bose LB2001 LBO00001B2 2022-09-09
Other Devices Sharing Product Codes#