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Essity Hygiene and Health AB

Sweden · Gothenburg

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Canada, Australia, Russia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 5Class II 2Class III 0

plus 10 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

25registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

8active registrations

Class 1 8

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States10 registration records, 0 510(k), 0 PMA, 13 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia25 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Essity Hygiene Y Salud Mexico, S.A. DE C.V. · Essity Hygiene and Health AB · Essity Hygiene Health AB · ESSITY HYGIENE AND HEALTH AB

FDA listed device types

Pad, Menstrual, Unscented 1Garment, Protective, For Incontinence 1Cover, Mattress (Medical Purposes) 1Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile 1Pad, Menstrual, Reusable 1Alarm, Conditioned Response Enuresis 1Pad, Menstrual, Scented, Scented-Deodorized 1

Market	Identifier	Name	Class / date
SA	ME0000005527SFDAA00001	TENA MEN PU L4 LARGE	—
SA	ME0000005527SFDAA00013	Tena Lady Pants Discreet Plus XL	—

Essity Hygiene and Health AB

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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