Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033526650

FEI Number

3033526650

Entity Name

Solis Hygiene Pvt. Ltd.

City/State/Country

Dhar Indore Madhya Pradesh, IN

Establishment Address

Plot No. 8, Integrated I/A, Pithampur No. 5, Pithampur, Dist., Dhar Indore Madhya Pradesh 454775, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Solis Hygiene Pvt. Ltd. (Owner Number: 10091578)

Owner / Operator Contact Address

Plot No. 8, Integrated I/A,, Pithampur No. 5, Pithampur, Dist.-Dhar Indore, IN-NOTA 454775, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Incontinence Protection Menstrual Pad Disposable Bedding

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2024-10-16
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2024-10-16
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-10-16

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Solis Hygiene Pvt. Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

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3010048541	ABENA NORTH AMERICA, INC.	Oceanside, CA, US
3016452317	GUANGDONG CHUANTIAN SANITARY PRODUCTS CO.,LTD	Zhongshan Guangdong, CN
3012162353	INTELLIGENT FABRIC TECHNOLOGIES (NORTH AMERICA) INC.	Markham Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033526650. Last updated year: 2026. Please use registration number 3033526650 when referencing this establishment in official correspondence.