Real-Ear

FDA UDI

Class II (US FDA UDI)

by WS Audiology USA, Inc.

Identity

Trade Name: REAL-EAR FDA UDI
Generic Name: Audiometric/hearing aid tester FDA UDI
Device Name: REAL-EAR EAR HANGER FDA UDI
Model / Reference: REAL-EAR EAR HANGER FDA UDI
Description: REAL-EAR EAR HANGER FDA UDI

Identifiers

Catalog Number: 10823943 FDA UDI
Primary DI / UDI-DI: 05711781000183 FDA UDI
FDA Product Code: EWO FDA UDI
GMDN Term: Audiometric/hearing aid tester FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Audiometric/hearing aid tester

Real-Ear by WS Audiology USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: WS Audiology USA, Inc.

Sources (1)

FDA UDI aa0e630d-094d-4d1e-b012-976a95657ea1 35 fields · synced May 31, 2026