← Back to catalogue

Oticon

FDA UDI

Class II (US FDA UDI)

by Oticon A/S

Identity

Trade Name
Oticon FDA UDI
Generic Name
Air-conduction hearing aid, receiver-in-the-ear FDA UDI
Device Name
AGIL, RITE SIL FDA UDI
Model / Reference
104-23-504-00 FDA UDI
Description
AGIL, RITE SIL FDA UDI

Identifiers

Catalog Number
104-23-504-00 FDA UDI
Primary DI / UDI-DI
05707131151186 FDA UDI
FDA Product Code
OSM FDA UDI
GMDN Term
Air-conduction hearing aid, receiver-in-the-ear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3305 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
MRI Safety
MR Unsafe FDA UDI

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

Oticon by Oticon A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Oticon A/S

Sources (1)

  • FDA UDI 8d846e38-2b4e-41c0-ba79-49e17663ab8e 35 fields · synced May 31, 2026