UE LifeSciences (India) Pvt Ltd

FDA Device Registration & Listing · Mumbai Maharashtra, IN · Registration 3013951855

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013951855
FEI Number
3013951855
Entity Name
UE LifeSciences (India) Pvt Ltd
City/State/Country
Mumbai Maharashtra, IN
Establishment Address
302 Trimbak Niwas, Relcon House, M.G. Road, Vile Parle (East), Mumbai Maharashtra 400057, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
UE LifeSciences Inc. (Owner Number: 10044277)
Owner / Operator Contact Address
3401 Market St, Suite 200, Philadelphia, PA 19104, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190575
PMA Number
N/A

All Registered Proprietary Names

iBreastExam iBreastExam Gen2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LHQ System, Telethermographic (Adjunctive Use) Obstetrics/Gynecology Class 1 884.2980 2013-05-20
NKA System, Documentation, Breast Lesion Obstetrics/Gynecology Class 2 884.2990 2019-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

Mihir Shah Business: UE LifeSciences Inc. Email: Info@uelifesciences.com Phone: (267) 3423303

Related Public Records

Same Entity

UE LifeSciences Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010914393 UE LIFESCIENCES INC. Philadelphia, PA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013951855. Last updated year: 2026. Please use registration number 3013951855 when referencing this establishment in official correspondence.
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