GN ReSound

FDA UDI

Class II (US FDA UDI)

by Gn Hearing A/S

Identity

Trade Name: GN ReSound FDA UDI
Generic Name: Air-conduction hearing aid, receiver-in-canal FDA UDI
Device Name: HI,RE562-DRWT,BLK FDA UDI
Model / Reference: 21230808 FDA UDI
Description: HI,RE562-DRWT,BLK FDA UDI

Identifiers

Primary DI / UDI-DI: 05708296180387 FDA UDI
FDA Product Code: OSM FDA UDI
GMDN Term: Air-conduction hearing aid, receiver-in-canal 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

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

GN ReSound by Gn Hearing 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-canal.

SET CROS PURE CHARGE&GO PRL — Signia GmbH · Class IIa
HA EVK E-FS-T USA 440 SLVGR — Widex A/S · Class IIa
AGXO — Sbo Hearing A/S · Class IIa
SoniTon UP6 312 trial — Sonova AG · Class IIa
HA VIO E156 T BC LI GPH — WSAUD A/S · Class IIa
HANSATON — Hansaton Akustik GmbH · Class II
PHONAK — Sonova AG · Class II
AMPLIFON — Starkey Laboratories Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Gn Hearing A/S

Sources (1)

FDA UDI 8181c9e8-999e-49d0-8a3c-b1f20163ab4a 34 fields · synced May 30, 2026