Miracle-Ear

FDA UDI

Class II (US FDA UDI)

by WS Audiology USA, Inc.

Identity

Trade Name: Miracle-Ear FDA UDI
Generic Name: Contralateral hearing unit FDA UDI
Device Name: MECROS RF 10 XP R Mocha-Red FDA UDI
Model / Reference: MECROS RF 10 XP R FDA UDI
Description: MECROS RF 10 XP R Mocha-Red FDA UDI

Identifiers

Catalog Number: 10982168 FDA UDI
Primary DI / UDI-DI: 04056839133217 FDA UDI
FDA Product Code: OSM FDA UDI
KLW FDA UDI
GMDN Term: Contralateral hearing unit FDA UDI

Classification

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Contralateral hearing unit

Miracle-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 4e7fb32c-3448-4692-88e7-0e0d8ce2bdb4 35 fields · synced May 30, 2026