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Diopsys®

FDA UDI

Class II (US FDA UDI)

by Diopsys, Inc.

Identity

Trade Name
Diopsys® FDA UDI
Generic Name
Vision electrophysiology analysis system FDA UDI
Device Name
Disposable Hypoallergenic EEG Electrodes, Case/300 FDA UDI
Model / Reference
6020-0001-01 FDA UDI
Description
Disposable Hypoallergenic EEG Electrodes, Case/300 FDA UDI

Identifiers

Primary DI / UDI-DI
10850514007036 FDA UDI
510(k) Number
K101763 FDA UDI
FDA Product Code
GWE FDA UDI
GMDN Term
Vision electrophysiology analysis system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vision electrophysiology analysis system

Diopsys® by Diopsys, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vision electrophysiology analysis system.

Cleared under the same submission

K101763 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diopsys, Inc.

Sources (1)

  • FDA UDI 7f924d2e-130d-4a69-80d8-1af3f6bffa83 34 fields · synced May 30, 2026