GN ReSound

FDA UDI

Class I (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,VE362-DVIR,RIE,BLK FDA UDI
Model / Reference: 19185204 FDA UDI
Description: HI,VE362-DVIR,RIE,BLK FDA UDI

Identifiers

Primary DI / UDI-DI: 05704819249944 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

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 I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Gn Hearing A/S

Sources (1)

FDA UDI 3b4206b1-f98a-4bea-b28d-6a51e1b1aa3c 34 fields · synced Jun 1, 2026