Data / Medical devices / Hungary / Hyginett Hungarian American Co. For The Production

Hyginett Hungarian American Co. For The Production: FDA-registered device maker in CSOMOR Pest, Hungary, 2 510(k) clearances

Name: Hyginett Hungarian American Co. For The Production FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hyginett Hungarian American Co. For The Production is registered with the FDA (registration 3004443383) in CSOMOR Pest, Hungary. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 27, 2008. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004443383
Address: Hatar U.3, CSOMOR Pest, Hungary, 2141
Owner or operator: P&G HUNGARY KKT (9060656)
Roles: Manufacturer
First device listed: February 29, 2008
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Tampon, Menstrual, Scented, Scented-Deodorized	HIL	2	Manufacturer	accessdata.fda.gov
Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	NRC	1	Manufacturer	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Manufacturer	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 27, 2008	K081555	TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED	HIL	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
November 22, 2006	K062638	TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS	HEB	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov

Compare with other makers

Updated June 27, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.