Solero

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc

Identity

Trade Name: Solero FDA UDI
Generic Name: Microwave hyperthermia system FDA UDI
Device Name: Solero MTA Cart FDA UDI
Model / Reference: H787127401380 FDA UDI
Description: Solero MTA Cart FDA UDI

Identifiers

Primary DI / UDI-DI: H787127401380 FDA UDI
510(k) Number: K182250 FDA UDI
FDA Product Code: NEY FDA UDI
GMDN Term: Microwave hyperthermia system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 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: Microwave hyperthermia system

Solero by Angiodynamics, Inc — 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: Angiodynamics, Inc

Sources (1)

FDA UDI c2fe6674-1cca-40ed-aaf4-d8008bbe2753 35 fields · synced Jun 20, 2026