INITO HEALTH TECH PRIVATE LIMITED

FDA Device Registration & Listing · Bangalore, Bangalore South Karnataka, IN · Registration 3038290392

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
3038290392
FEI Number
3038290392
Entity Name
INITO HEALTH TECH PRIVATE LIMITED
City/State/Country
Bangalore, Bangalore South Karnataka, IN
Establishment Address
No. 4, Indiqube Prism, 1st, 2nd & 3rd Floor, Industrial Layout, Koramangala Extension, Koramangala VI Bk, Bangalore, Bangalore South Karnataka 560095, IN
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Inito Health Tech Private Limited (Owner Number: 10093348)
Owner / Operator Contact Address
No. 4, Indiqube Prism, 1st, 2nd & 3rd Floor, Industrial Layout, Koramangala Extension, Koramangala VI Bk, Bangalore, Bangalore South, IN-KA 560095, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Inito Fertility Tracker - InSight Reader / Inito Fertility Monitor; InSight Wireless Reader Fertility Strip / Inito Fertility Monitor Strip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2025-05-07

Official Correspondent

Varun Av

US Agent Details

Lilian Llull Email: lilian@techlinkusa.net Phone: (305) 2066777

Related Public Records

Same Entity

Inito Health Tech Private Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038290392. Last updated year: 2026. Please use registration number 3038290392 when referencing this establishment in official correspondence.
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