Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035641077

FEI Number

3035641077

Entity Name

BALAJI INDUSTRIES

City/State/Country

Navi Mumbai Maharashtra, IN

Establishment Address

A-324, TTC Industrial Area, Mahape MIDC, Mahape, Navi Mumbai Maharashtra 400710, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Balaji Industries (Owner Number: 10092325)

Owner / Operator Contact Address

A-324, TTC Industrial Area, Mahape MIDC, Mahape, Navi Mumbai, IN-MH 400710, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Water Cool Jel Hydrogel Water Cool Jel Clear Hydrogel Water Cool Jel Hydrogel Foam Water Cool Jel Hydrogel Spray Water Cool Jel Hydrogel Dressing Water Cool Jel Bandage Water Cool Jel Hydrogel Gauze Pads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-12-24

Official Correspondent

Sagar Dhadke

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (570) 1516482

Related Public Records

Same Entity

Balaji Industries

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3038014307	CURAPEP LLC	Burlington, WI, US
3043012215	ZENESIS HOLDINGS CO., LIMITED	Kowloon, HK
3008646686	KIKGEL	Ujazd Opolskie, PL
8043484	Smith & Nephew Medical Ltd	HULL East Riding of Yorkshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035641077. Last updated year: 2026. Please use registration number 3035641077 when referencing this establishment in official correspondence.