Unitron Brand

FDA UDI

Class II (US FDA UDI)

by Sonova AG

Identity

Trade Name: Unitron Brand FDA UDI
Generic Name: Noninvasive device battery charger FDA UDI
Device Name: Unitron Charger Combi BTE no EPS FDA UDI
Model / Reference: 075-5869-10 FDA UDI
Description: Unitron Charger Combi BTE no EPS FDA UDI

Identifiers

Primary DI / UDI-DI: 07613389551020 FDA UDI
FDA Product Code: OSM FDA UDI
GMDN Term: Noninvasive device battery charger 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: Noninvasive device battery charger

Unitron Brand by Sonova AG — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Sonova AG

Sources (1)

FDA UDI 8513aaf0-c900-4f97-abfa-baed660e8f1c 33 fields · synced Jun 8, 2026