Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016702790

FEI Number

3016702790

Entity Name

SIRONA HYGIENE PRIVATE LIMITED

City/State/Country

New Delhi, IN

Establishment Address

3rd and 4th Floor, Apex Tower, Gaushala Marg, Kishan Garh,, Pocket B-C, Sector A, Vasant Kunj, New Delhi 110070, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIRONA HYGIENE PRIVATE LIMITED (Owner Number: 10081860)

Owner / Operator Contact Address

3rd and 4th Floor, Apex Tower, Gaushala Marg, Kishan Garh,, Pocket B-C, Sector A, Vasant Kunj,, New Delhi, IN-DL 110070, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sirona Sirona Peebuddy - Urination Funnels Peebuddy - Urination Funnels Peebuddy - Urination Funnels

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHL	Pad, Menstrual, Scented, Scented-Deodorized	Obstetrics/Gynecology	Class 2	884.5425	2021-05-21
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2021-05-21
MNG	External Urethral Occluder, Urinary Incontinence-Control, Female	Gastroenterology, Urology	Class 1	876.5160	2021-07-16
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2021-07-16
FNP	Urinal	General Hospital	Class 1	880.6730	2021-07-16

Official Correspondent

Mohit Bajaj

US Agent Details

Bharat Mandot Business: STELCORE MANAGEMENT SERVICES LLC Email: bharatmandot@yahoo.com Phone: (281) 8197875

Related Public Records

Same Entity

SIRONA HYGIENE PRIVATE LIMITED

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
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

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3006542627	Guangdong Kawada Sanitary Products Co.,Ltd. Southern District Branch Company.	GUANG DONG Guangdong, CN
3019469637	SYNCWORKS COMPANY LIMITED	Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016702790. Last updated year: 2026. Please use registration number 3016702790 when referencing this establishment in official correspondence.