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Hearing Aid Feature 2.0 (HAF 2.0)

FDA UDI

Class II (US FDA UDI)

by Apple Inc.

Identity

Trade Name
Hearing Aid Feature 2.0 (HAF 2.0) FDA UDI
Generic Name
Air-conduction hearing aid, in-the-ear FDA UDI
Device Name
Hearing Aid Feature watchOS (2.X) FDA UDI
Model / Reference
Feature version 2.X FDA UDI
Description
Hearing Aid Feature watchOS (2.X) FDA UDI

Identifiers

Primary DI / UDI-DI
00195950732399 FDA UDI
510(k) Number
DEN230081 FDA UDI
FDA Product Code
SCR FDA UDI
GMDN Term
Air-conduction hearing aid, in-the-ear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3335 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Hearing Aid Feature 2.0 (HAF 2.0) by Apple Inc. — Class II — 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
Apple Inc.

Sources (1)

  • FDA UDI b1e955ce-14a3-4dee-bbab-efada877d8f7 34 fields · synced May 30, 2026