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Persona Medical

FDA UDI

Class I (US FDA UDI)

by Persona Medical

Identity

Trade Name
Persona Medical FDA UDI
Generic Name
Air-conduction hearing aid, in-the-ear FDA UDI
Device Name
8 Channel Programmable CIC faceplate module (Standard/Power) to be used to manufacture a custom hearing aid. FDA UDI
Model / Reference
Evok 900 CIC Std/Pwr FDA UDI
Description
8 Channel Programmable CIC faceplate module (Standard/Power) to be used to manufacture a custom hearing aid. FDA UDI

Identifiers

Primary DI / UDI-DI
00851362008292 FDA UDI
FDA Product Code
LRB FDA UDI
GMDN Term
Air-conduction hearing aid, in-the-ear FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Category: Air-conduction hearing aid, in-the-ear

Persona Medical by Persona Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Persona Medical

Sources (1)

  • FDA UDI 04f3593f-e638-4559-935f-f76c490e4ab1 33 fields · synced May 30, 2026