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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 R R AX Deep Brown FDA UDI
Model / Reference
MECROS R R AX FDA UDI
Description
MECROS R R AX Deep Brown FDA UDI

Identifiers

Catalog Number
21004040 FDA UDI
Primary DI / UDI-DI
05714880135169 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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

Similar devices

Also classified as Contralateral hearing unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
WS Audiology USA, Inc.

Sources (1)

  • FDA UDI ea698208-9ca3-4bbc-9f0b-9ae43a28a9cc 35 fields · synced Jun 8, 2026