Hansaton

FDA UDI

Class II (US FDA UDI)

by Hansaton Akustik GmbH

Identity

Trade Name: HANSATON FDA UDI
Generic Name: Air-conduction hearing aid, receiver-in-canal FDA UDI
Device Name: Oro-Enhanced Clarity (Grey) FDA UDI
Model / Reference: 050-5742-U569 FDA UDI
Description: Oro-Enhanced Clarity (Grey) FDA UDI

Identifiers

Catalog Number: 050-5742-U569 FDA UDI
Primary DI / UDI-DI: 07613389094640 FDA UDI
FDA Product Code: KLW FDA UDI
OSM FDA UDI
GMDN Term: Air-conduction hearing aid, receiver-in-canal FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3400 FDA UDI
874.3305 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Air-conduction hearing aid, receiver-in-canal

The Hansaton HANSATON is a battery-powered, behind-the-ear acoustic device designed to compensate for impaired hearing. It consists of a microphone and amplifier in a BTE case connected via a wire to a receiver (speaker) in the ear canal. The device is used for mild to profound hearing loss and can be programmable to adjust for patient-specific factors. With its Grey color, this device offers enhanced clarity and sound quality, making it an ideal solution for individuals with tinnitus or hearing loss.

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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: Hansaton Akustik GmbH

Sources (1)

FDA UDI 9a46d3aa-ffff-4c64-9b8e-850fd69973ac 35 fields · synced Jul 30, 2026