Data / Medical devices / India / UE LifeSciences (India) Pvt Ltd
UE LifeSciences (India) Pvt Ltd: FDA-registered device maker in Mumbai Maharashtra, India, 3 510(k) clearances
UE LifeSciences (India) Pvt Ltd is registered with the FDA (registration 3013951855) in Mumbai Maharashtra, India. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013951855
- Address
- 302 Trimbak Niwas, Relcon House M.G. Road, Vile Parle (East), Mumbai Maharashtra, India, 400057
- Owner or operator
- UE LifeSciences Inc. (10044277)
- Roles
- Manufacturer
- First device listed
- May 20, 2013
- Registered through
- 2026
- Brand names listed
- iBreastExam, iBreastExam Gen2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Documentation, Breast Lesion | NKA | 2 | Manufacturer | accessdata.fda.gov |
| System, Telethermographic (Adjunctive Use) | LHQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 16, 2019 | K190575 | iBreastExam | NKA | Substantially Equivalent | Ue Lifesciences, Inc. | accessdata.fda.gov |
| April 23, 2015 | K142926 | iBreastExam | NKA | Substantially Equivalent | Ue Lifesciences, Inc. | accessdata.fda.gov |
| February 10, 2012 | K113259 | NOTOUCH BREASTSCAN | LHQ | Substantially Equivalent | Ue Lifesciences, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Documentation, Breast Lesion
- All makers of System, Telethermographic (Adjunctive Use)
Updated July 16, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.