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Welch Allyn, Inc.

FDA UDI

Class I (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name
Welch Allyn, Inc. FDA UDI
Generic Name
Vision physiology/eye movement analysis system FDA UDI
Device Name
REFURB SPOT VISION SCREENER W CASE UK FDA UDI
Model / Reference
901029 FDA UDI
Description
REFURB SPOT VISION SCREENER W CASE UK FDA UDI

Identifiers

Catalog Number
VS100S-4R FDA UDI
Primary DI / UDI-DI
00732094322385 FDA UDI
FDA Product Code
HKO FDA UDI
GMDN Term
Vision physiology/eye movement analysis system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1760 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vision physiology/eye movement analysis system

Welch Allyn, Inc. by Welch Allyn, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vision physiology/eye movement analysis system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Welch Allyn, Inc.

Sources (1)

  • FDA UDI f1b1655b-c5d9-4bf7-addf-4eb19476bc59 35 fields · synced May 30, 2026