GN Otometrics A/S

FDA UDI

Class II (US FDA UDI)

by Natus Medical Denmark ApS

Identity

Trade Name: GN Otometrics A/S FDA UDI
Generic Name: Impedance audiometer FDA UDI
Model / Reference: Eartip Box, Large FDA UDI

Identifiers

Primary DI / UDI-DI: 05713315003929 FDA UDI
510(k) Number: K033645 FDA UDI
FDA Product Code: ETY FDA UDI
GMDN Term: Impedance audiometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1090 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Category: Impedance audiometer

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

Similar devices

Also classified as Impedance audiometer.

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Silicone Ear Tips — Natus Medical Denmark ApS · Class I
1096 Madsen Zodiac Quick Check Probe Gen 2 — Natus Medical Denmark ApS · Class IIa
Amplivox — Amplivox, Ltd. · Class II
Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
VIOLA — INVENTIS SRL · Class II
Silicone Ear Tips — Natus Medical Denmark ApS · Class I
nanoTymp Set — PATH medical GmbH · Class II

Cleared under the same submission

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 11c3b85d-977a-4467-9dbd-6cabcd3f74bf 33 fields · synced Jun 1, 2026