Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710120

FEI Number

3003349476

Entity Name

Essity Operations Gennep B.V.

City/State/Country

GENNEP Limburg, NL

Establishment Address

HOOGVELD 25, 6598 BL HEIJN POSBUS 19, GENNEP Limburg 6590 AA, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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® Air Flow Underpad TENA InstaDri Air Underpad TENA® Underpads 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 TENA SmartCare Identifi TENA SmartCare Change Indicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	1996-07-24
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2003-01-29
KPN	Alarm, Conditioned Response Enuresis	Gastroenterology, Urology	Class 2	876.2040	2014-02-18

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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780660	Nite Train-R Enterprises, Inc.	NITE TRAIN'R	1978-07-28
K871787	Dilorenzo Engineering Co.	ENURESIS ALARM	1987-08-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710120. Last updated year: 2026. Please use registration number 9710120 when referencing this establishment in official correspondence.