Natus

FDA UDI

Class II (US FDA UDI)

by Natus Medical Denmark ApS

Identity

Trade Name: Natus FDA UDI
Generic Name: Evoked-potential audiometer FDA UDI
Device Name: Acculink Software FDA UDI
Model / Reference: 8-49-88800 FDA UDI
Description: Acculink Software FDA UDI

Identifiers

Catalog Number: 8-49-88800 FDA UDI
Primary DI / UDI-DI: 05713315008672 FDA UDI
FDA Product Code: GWJ FDA UDI
GMDN Term: Evoked-potential audiometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1900 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Evoked-potential audiometer

Natus by Natus Medical Denmark ApS — 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: Natus Medical Denmark ApS

Sources (1)

FDA UDI 96d1f559-150c-486d-b3ce-8044180e3f2b 34 fields · synced Jun 7, 2026