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Neuropack S3

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden Corp.

Identity

Trade Name
Neuropack S3 FDA UDI
Generic Name
Evoked-potential graphic recording system FDA UDI
Device Name
POWER SUPPLY UNIT for LAPTOP PC (100-120V) FDA UDI
Model / Reference
SC-900B FDA UDI
Description
POWER SUPPLY UNIT for LAPTOP PC (100-120V) FDA UDI

Identifiers

Primary DI / UDI-DI
04931921005552 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Evoked-potential graphic recording system

Neuropack S3 by Nihon Kohden Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evoked-potential graphic recording system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nihon Kohden Corp.

Sources (1)

  • FDA UDI 90b6c166-a568-4ea0-8ed0-4452f25f3026 34 fields · synced Jun 8, 2026