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Mepower I 3 5p Ite-R Wl Ph

FDA UDI

Class II (US FDA UDI)

by Sonova AG

Identity

Trade Name
MEPOWER I 3 5P ITE-R WL PH FDA UDI
Generic Name
Air-conduction hearing aid, in-the-ear FDA UDI
Model / Reference
R WL PH FDA UDI

Identifiers

Catalog Number
063-0528-01B1 FDA UDI
Primary DI / UDI-DI
07613389772890 FDA UDI
FDA Product Code
OSM FDA UDI
KLW FDA UDI
GMDN Term
Air-conduction hearing aid, in-the-ear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3305 FDA UDI
874.3400 FDA UDI
Commercial Distribution
Not 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

No

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Mepower I 3 5p Ite-R Wl Ph by Sonova AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sonova AG

Sources (1)

  • FDA UDI ad3f4282-0a63-4550-867e-02fa9a022791 34 fields · synced May 30, 2026