uMI

FDA UDI

Class II (US FDA UDI)

by Uih Technologies, Llc

Identity

Trade Name: uMI FDA UDI
Generic Name: PET/CT system FDA UDI
Device Name: The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals. FDA UDI
Model / Reference: uMI 550 FDA UDI
Description: The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810030350088 FDA UDI
FDA Product Code: KPS FDA UDI
JAK FDA UDI
GMDN Term: PET/CT system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1200 FDA UDI
892.1750 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

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: PET/CT system

uMI by Uih Technologies, Llc — 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: Uih Technologies, Llc

Sources (1)

FDA UDI 577fdc1e-1433-4dad-8a91-fbbd46683807 33 fields · synced Jun 1, 2026