Au V1-R

FDA UDIEUDAMED

Class II (US FDA UDI)

by Sonova AG

Identity

Trade Name: Au V1-R FDA UDI
Generic Name: Air-conduction hearing aid, receiver-in-canal FDA UDI
Model / Reference: espresso FDA UDI

Identifiers

Catalog Number: 050-6510-P474 FDA UDI
Primary DI / UDI-DI: 07613389798890 FDA UDI
FDA Product Code: OSM FDA UDI
KLW 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
874.3400 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

Yes

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

Au V1-R by Sonova AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sonova AG

Sources (2)

FDA UDI f05dc786-73db-42fe-a186-40f55a4eece1 34 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 1, 2026