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 Battery Pack for MPT-II Thermal Printer; Lithium-Ion FDA UDI
Model / Reference: 901122 FDA UDI
Description: Welch Allyn Battery Pack for MPT-II Thermal Printer; Lithium-Ion FDA UDI

Identifiers

Catalog Number: 39416 FDA UDI
Primary DI / UDI-DI: 00732094186314 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

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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.

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Otoscope — Rashman Corp. · Class I
Otoscope — Rashman Corp. · Class I
zumax — Zumax Medical Co., LTD · Class I
zumax — Zumax Medical Co., LTD · Class I
zumax — Zumax Medical Co., LTD · Class I
zumax — Zumax Medical Co., LTD · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Welch Allyn, Inc.

Sources (1)

FDA UDI 9e12a3ae-9095-4285-9a45-8a62bb76ac19 35 fields · synced Jun 7, 2026