Bio-logic

FDA UDI

Class II (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name: Bio-logic FDA UDI
Generic Name: Auditory stimulator FDA UDI
Device Name: The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. FDA UDI
Model / Reference: ABR Standard Insert Earphones 8 ft FDA UDI
Description: The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. FDA UDI

Identifiers

Catalog Number: 580-SINABR-008 FDA UDI
Primary DI / UDI-DI: 00382830052467 FDA UDI
510(k) Number: K031352 FDA UDI
FDA Product Code: EWO FDA UDI
GMDN Term: Auditory stimulator 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 8 Feet FDA UDI

Category: Auditory stimulator

Bio-logic by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Auditory stimulator.

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GN Otometrics A/S — Natus Medical Denmark ApS · Class II
Nucleus — Cochlear · Class III
GN Otometrics A/S — Natus Medical Denmark ApS · Class II
OAE EarTips — Natus Medical Denmark ApS · Class I
Madsen Accuscreen — Natus Medical Denmark ApS · Class IIa

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 Incorporated

Sources (1)

FDA UDI c0061f4e-c745-407f-84ce-f091550294c3 37 fields · synced Jun 1, 2026