Philips

FDA UDI

Class II (US FDA UDI)

by Sedecal., Sa.

Identity

Trade Name: Philips FDA UDI
Generic Name: Mobile basic diagnostic x-ray system, digital FDA UDI
Device Name: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for mammography FDA UDI
Model / Reference: MobileDiagnost wDR 2.2 FDA UDI
Description: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for mammography FDA UDI

Identifiers

Primary DI / UDI-DI: 08436046002357 FDA UDI
FDA Product Code: IZL FDA UDI
MQB FDA UDI
GMDN Term: Mobile basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1720 FDA UDI
892.1680 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mobile basic diagnostic x-ray system, digital

Philips by Sedecal., Sa. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Sedecal., Sa.

Sources (1)

FDA UDI ff1ea6f4-88fb-4067-b8ea-214fb17af0dc 34 fields · synced May 31, 2026