NIRAMAI HEALTH ANALYTIX

FDA Device Registration & Listing · Bangalore Karnataka, IN · Registration 3018553169

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
3018553169
FEI Number
3018553169
Entity Name
NIRAMAI HEALTH ANALYTIX
City/State/Country
Bangalore Karnataka, IN
Establishment Address
Niramai Health Analytix Pvt Ltd, Innova Pearl, No. 17, 5th Block, Koramangala, Bangalore Karnataka 560095, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NIRAMAI Health Analytix Pvt Ltd (Owner Number: 10086919)
Owner / Operator Contact Address
Niramai Health Analytix Pvt Ltd, Innova Pearl, No. 17, 5th Block, Koramangala, Bangalore, IN-KA 560095, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

MammoBuddy BreastHealth-100 SMILE-100 System

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 2022-12-22

Official Correspondent

Geetha Manjunath

US Agent Details

Jenisa Ramprasad Business: NIRAMAI Health Analytix Email: jenisa.ramprasad@niramai.com Phone: (917) 8268062

Related Public Records

Same Entity

NIRAMAI Health Analytix Pvt Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018553169. Last updated year: 2026. Please use registration number 3018553169 when referencing this establishment in official correspondence.
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