Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003952845

FEI Number

3003952845

Entity Name

Essity Slovakia s.r.o.

City/State/Country

GEMERSKA-HORKA Kosicky, SK

Establishment Address

PERNEROVA 11, GEMERSKA-HORKA Kosicky SK-04912, SK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Essity Hygiene and Health AB (Owner Number: 9040833)

Owner / Operator Contact Address

Molndal Bro 2, Gothenburg, SE-O SE-405 03, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TENA® Dry Comfort Briefs Carefree Serenity lights by TENA TENA Intimates TENA Stylish TENA Comfort / TENA ProSkin Fully Breathable Absorbent Pads TENA Stretch / TENA ProSkin Stretch Briefs TENA ProSkin Stretch Ultra Briefs 2XL TENA Super / TENA ProSkin Super Briefs TENA Fixation / TENA ProSkin Comfort Pants TENA Men Super Plus TENA® Stretch Plus Briefs 2XL TENA Sensitive Care TENA ProSkin Stretch Super Briefs 3XL TENA ProSkin Plus Protective Underwear TENA® Stretch Plus Briefs TENA Ultra / TENA ProSkin Ultra Briefs TENA ProSkin Overnight Super Protective Underwear TENA Dry Comfort® Protective Underwear TENA ProSkin Extra Protective Underwear TENA Intimates Overnight TENA Men Shield TENA ProSkin Underwear for Women TENA ProSkin Flex TENA ProSkin® Plus XS Brief TENA ProSkin Underwear for Men TENA® Complete Briefs TENA Sensitive Care Overnight TENA® Classic Protective Underwear TENA Proskin TENA Men Guard Stayfree TENA Complete +Care Ultra Briefs

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	2003-01-29

Official Correspondent

No official correspondent registered.

US Agent Details

Sean Anderson Business: ESSITY HMS NORTH AMERICA INC. Email: RegistrationTeamCLT@essity.com Phone: (959) 5997401

Related Public Records

Same Entity

Essity Hygiene and Health AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015114852	Essity Netherlands B.V.	Zeist Utrecht, NL
3014559678	ESSITY OPERATION POLAND Sp.Z o. o.	Olawa, Poland Slaskie, PL
9710130	Essity Hygiene Health AB	FALKENBERG Halland, SE
8030877	Essity Hygiene and Health AB	Gothenburg Vastra Gotaland, SE
1039577	Essity HMS North America Inc.	BOWLING GREEN, KY, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003952845. Last updated year: 2026. Please use registration number 3003952845 when referencing this establishment in official correspondence.