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Otometrics

FDA UDI

Class II (US FDA UDI)

by Natus Medical Denmark ApS

Identity

Trade Name
Otometrics FDA UDI
Generic Name
Tone audiometer FDA UDI
Device Name
1081 Madsen A450, ANSI Cal., Incl. HB-8 Headset and Insert Phone (US only) FDA UDI
Model / Reference
Madsen A450 FDA UDI
Description
1081 Madsen A450, ANSI Cal., Incl. HB-8 Headset and Insert Phone (US only) FDA UDI

Identifiers

Catalog Number
8-04-14562 FDA UDI
Primary DI / UDI-DI
05713315005978 FDA UDI
FDA Product Code
EWO FDA UDI
GMDN Term
Tone audiometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tone audiometerSpeech audiometer

Otometrics by Natus Medical Denmark ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Speech audiometer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Denmark ApS

Sources (1)

  • FDA UDI a5a46fb5-6563-418e-9c06-0a562a1833a9 34 fields · synced May 29, 2026