← Back to catalogue

GN Hearing

FDA UDI

Class I (US FDA UDI)

by Gn Hearing A/S

Identity

Trade Name
GN Hearing FDA UDI
Generic Name
Air-conduction hearing aid, receiver-in-canal FDA UDI
Device Name
REC TUBE,SF2B HP REC,2R,BLSTR FDA UDI
Model / Reference
21308000 FDA UDI
Description
REC TUBE,SF2B HP REC,2R,BLSTR FDA UDI

Identifiers

Primary DI / UDI-DI
05708296200023 FDA UDI
FDA Product Code
ESD FDA UDI
GMDN Term
Air-conduction hearing aid, receiver-in-canal 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Air-conduction hearing aid, receiver-in-canal

GN Hearing by Gn Hearing A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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
Gn Hearing A/S

Sources (1)

  • FDA UDI ba5260cb-082d-4ea3-ad5d-6df5ca3689c5 34 fields · synced Jun 7, 2026