Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030877

FEI Number

3005155428

Entity Name

Essity Hygiene and Health AB

City/State/Country

Gothenburg Vastra Gotaland, SE

Establishment Address

Molndal Bro 2, Gothenburg Vastra Gotaland SE-405 03, SE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,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 SmartCare Identifi TENA SmartCare Change Indicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUQ	Pad, Menstrual, Reusable	Obstetrics/Gynecology	Class 1	884.5435	2023-11-27
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
1039577	Essity HMS North America Inc.	BOWLING GREEN, KY, US
3014579083	ESSITY DO BRASIL INDUSTRIA E COMERCIO	Jarinu Sao Paulo, BR

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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3030979401	Everylife Inc	West Palm Beach, FL, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030877. Last updated year: 2026. Please use registration number 8030877 when referencing this establishment in official correspondence.