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NeurOptics

FDA UDIEUDAMED

Class I (US FDA UDI)

by NeurOptics, Inc.

Identity

Trade Name
NeurOptics FDA UDI
Generic Name
Pupillograph FDA UDI
Device Name
Box of 24 Smart Guards FDA UDI
Model / Reference
SG-200 FDA UDI
Description
Box of 24 Smart Guards FDA UDI

Identifiers

Catalog Number
SG-200 FDA UDI
Primary DI / UDI-DI
10850010118038 FDA UDI
FDA Product Code
HLG FDA UDI
GMDN Term
Pupillograph FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pupillograph

NeurOptics by NeurOptics, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Pupillograph.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NeurOptics, Inc.

Sources (2)

  • FDA UDI 78003a5b-abde-417f-8a6d-62c52ab79b53 35 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced May 29, 2026