Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1039577

FEI Number

1039577

Entity Name

Essity HMS North America Inc.

City/State/Country

BOWLING GREEN, KY, US

Establishment Address

7030 LOUISVILLE RD., BOWLING GREEN, KY 42101, US

Establishment Type(s)

Repack or Relabel Medical Device,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® Air Flow Underpad TENA InstaDri Air Underpad TENA® Underpads

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

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3014579083	ESSITY DO BRASIL INDUSTRIA E COMERCIO	Jarinu Sao Paulo, BR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1039577. Last updated year: 2026. Please use registration number 1039577 when referencing this establishment in official correspondence.