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Welch Allyn, Inc.

FDA UDI

Class II (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name
Welch Allyn, Inc. FDA UDI
Generic Name
Direct otoscope/audiometer FDA UDI
Device Name
Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 220-240 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-E/F FDA UDI
Model / Reference
901035 FDA UDI
Description
Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 220-240 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-E/F FDA UDI

Identifiers

Catalog Number
92682 FDA UDI
Primary DI / UDI-DI
00732094144963 FDA UDI
FDA Product Code
EWO FDA UDI
GMDN Term
Direct otoscope/audiometer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1050 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: Direct otoscope/audiometer

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

Similar devices

Also classified as Direct otoscope/audiometer.

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 716357c8-9b6e-4539-887a-153c9758c453 35 fields · synced Jun 7, 2026