Echoport Case service kit

FDA UDI

Class II (US FDA UDI)

by Otodynamics

Identity

Trade Name: Echoport Case service kit FDA UDI
Generic Name: Otoacoustic emission system, line-powered FDA UDI
Device Name: Case (enclosure) service parts for Echoport FDA UDI
Model / Reference: EP-CASE-KIT FDA UDI
Description: Case (enclosure) service parts for Echoport FDA UDI

Identifiers

Primary DI / UDI-DI: 05060396172762 FDA UDI
FDA Product Code: EWO FDA UDI
GMDN Term: Otoacoustic emission system, line-powered 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Otoacoustic emission system, line-powered

Echoport Case service kit by Otodynamics — 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: Otodynamics

Sources (1)

FDA UDI 3a84fda1-55ce-4002-ae54-2b1e6a48c972 33 fields · synced May 30, 2026