Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004443383

FEI Number

3004443383

Entity Name

HYGINETT HUNGARIAN AMERICAN CO. FOR THE PRODUCTION

City/State/Country

CSOMOR Pest, HU

Establishment Address

HATAR U.3, CSOMOR Pest 2141, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

P&G HUNGARY KKT (Owner Number: 9060656)

Owner / Operator Contact Address

VACI UT 35, --, BUDAPEST, HU-NOTA 1134, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRC	Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	Obstetrics/Gynecology	Class 1	884.5425	2013-11-06
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2008-02-29
HIL	Tampon, Menstrual, Scented, Scented-Deodorized	Obstetrics/Gynecology	Class 2	884.5460	2014-05-02
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2014-05-02
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2010-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

Nadia Prather, PHD Business: PROCTER & GAMBLE CO. Email: prather.nn@pg.com Phone: (513) 6343768

Related Public Records

Same Entity

P&G HUNGARY KKT

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
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

Similar Registrations

Registration Number	Establishment Name	Location
3015492420	ATOMY CO., LTD.	Gongju-si Chungnam, KR
9615625	KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO.,LTD.BEIJING	DEVELOPMENT ZONE, BEIJING, CN
3033860110	FOSHAN YURUN SANITARY ARTICLE CO., LTD	Foshan Guangdong, CN
3007697999	KIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill	Lima Lima (Region), PE
3008111543	AAB (CHINA) CO., LTD.	Nanan City Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004443383. Last updated year: 2026. Please use registration number 3004443383 when referencing this establishment in official correspondence.