Neuropack

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden America, Inc.

Identity

Trade Name: Neuropack FDA UDI
Generic Name: Evoked-potential graphic recording system FDA UDI
Device Name: MEB-9400 Neuropack S1 desktop system; performs Evoked potentials, Nerve Conduction and Electromyography studies FDA UDI
Model / Reference: MEB-9400A FDA UDI
Description: MEB-9400 Neuropack S1 desktop system; performs Evoked potentials, Nerve Conduction and Electromyography studies FDA UDI

Identifiers

Catalog Number: MEB-9400A FDA UDI
Primary DI / UDI-DI: 00841983103575 FDA UDI
FDA Product Code: IKN FDA UDI
GMDN Term: Evoked-potential graphic recording system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1375 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

Yes

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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Evoked-potential graphic recording system

Neuropack by Nihon Kohden America, Inc. — 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: Nihon Kohden America, Inc.

Sources (1)

FDA UDI 2346a9cf-673a-45f4-acf1-8981c9b777b2 35 fields · synced Jun 8, 2026