Neuropack S3

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden America, Inc.

Identity

Trade Name: Neuropack S3 FDA UDI
Generic Name: Evoked-potential graphic recording system FDA UDI
Device Name: Preassembled MEB-9600 on Cart for MEB-9600 Neuropack S3 desktop system, performs Evoked potentials, nerve conduction and electromyography studies FDA UDI
Model / Reference: NPS3-LT-Cart2-ZA FDA UDI
Description: Preassembled MEB-9600 on Cart for MEB-9600 Neuropack S3 desktop system, performs Evoked potentials, nerve conduction and electromyography studies FDA UDI

Identifiers

Catalog Number: MEB-9600 FDA UDI
Primary DI / UDI-DI: 00841983104251 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 Unsafe FDA UDI

Category: Evoked-potential graphic recording system

Neuropack S3 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 fc89495f-db0c-43b0-87ec-49c9fc6cc95f 35 fields · synced May 30, 2026