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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
Air-conduction hearing aid, behind-the-ear FDA UDI
Device Name
S_ITE MEENERGY 4 RF R 5W S L MOC TBLU FDA UDI
Model / Reference
MEENERGY 4 RF R 5W S L MOC FDA UDI
Description
S_ITE MEENERGY 4 RF R 5W S L MOC TBLU FDA UDI

Identifiers

Catalog Number
21031343 FDA UDI
Primary DI / UDI-DI
05714880219036 FDA UDI
FDA Product Code
OSM FDA UDI
KLW FDA UDI
GMDN Term
Air-conduction hearing aid, behind-the-ear 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: Air-conduction hearing aid, behind-the-ear

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

Similar devices

Also classified as Air-conduction hearing aid, behind-the-ear.

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 43033cf4-9ded-462e-9e07-c3a52f4185ce 35 fields · synced Jun 6, 2026