X-OMAT EX II Developer and Replenisher

FDA UDI

Class I (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name: X-OMAT EX II Developer and Replenisher FDA UDI
Generic Name: X-ray film processing chemical, automatic FDA UDI
Device Name: X-OMAT EX II DEVELOPER AND REPL 2 X 20L FDA UDI
Model / Reference: X-OMAT EX II Developer and Replenisher FDA UDI
Description: X-OMAT EX II DEVELOPER AND REPL 2 X 20L FDA UDI

Identifiers

Catalog Number: 5274394 FDA UDI
Primary DI / UDI-DI: 60889975274393 FDA UDI
FDA Product Code: IWZ FDA UDI
GMDN Term: X-ray film processing chemical, automatic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1840 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: X-ray film processing chemical, automatic

X-OMAT EX II Developer and Replenisher by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Carestream Health, Inc.

Sources (1)

FDA UDI 805b9f8a-4284-45d1-9c14-9ccf2cde7d79 34 fields · synced Jun 8, 2026