Real-Ear Battery Pill 312A

by WS Audiology USA, Inc.

Real-Ear Battery Pill 312A (10823969) is a Class II device made by WS Audiology USA, Inc., listed in FDA GUDID since 22 Jan 2020 (UDI-DI 05711781000695), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05711781000695 UDI-DI	Date22 Jan 2020Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 05711781000695

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Real-Ear
Generic name: Audiometric/hearing aid tester
Model / Ref / Catalog: REAL-EAR BATTERY PILL 312A, 10823969

Primary DI / UDI-DI: 05711781000695
FDA product code: EWO
GMDN term: Audiometric/hearing aid tester

Device class: Class II
Regulation number: 874.1050
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Audiometric/hearing aid tester.

Other devices from WS Audiology USA, Inc.

MIRACLE EAR MEMINI I 5 5w ITC-R STD

Class II
MIRACLE EAR MEMINI I 4 5w ITC-R STD

Class II
MIRACLE EAR MEMINI I 3 5w ITC-R STD

Class II
CONNEXX Slim-RIC Travel Charger 2 RB

Class II

See all devices from WS Audiology USA, Inc. →

Properties

Prescription use
Premarket exempt
Manufacturing date

Other properties (12, all answered No)