Essity Hygiene and Health AB
SE-MF-000000004 · Sweden · Göteborg
Essity Hygiene and Health AB is registered in the European database on medical devices as a manufacturer, with 1 808 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 808 |
|---|
Devices declared under this manufacturer
- LIBRESSE ALL FLUID PRO Pl Norm 10x24p CE
- TENA Discreet Extra 6x10p B2 SRP
- TENA Discreet Maxi Mega 4x18p B3
- TENA Discreet Maxi Night 6x12p + sticker
- TENA Fix M, 8x25p, neutral
- TENA Lady Slim UM 10x28p B6 SRP
- TENA Pants Night Super M,42x1,Ps,East
- TENA Pants Normal XL 2x30p,INT,ProT
- TENA Pants Super Large, 2x30p, Ps
- TENA Silh PinkV Hipster WAU L 56x1p DTC
- TENA Silhouette Plus L 2x10p LW Noir SRP CODE FSC
- TENA Slip Maxi L Ps 54x1p ELA, PS East
Showing 12 of 1 808 declared devices.
Catalogue references include 754057, 760680, 761176, 761185, 780225, 793640.
European nomenclature codes declared: T04010103, T04010102, T0499, T04010104, T04010299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Essity Hygiene and Health AB (SE) · FDA 8030877 |
| Devices in EUDAMED | 1 808 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 1 808 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ESSITY HYGIENE AND HEALTH AB |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2017-10-18 |
Licence types: System (1).
Licensed under: TENA SMARTCARE IDENTIFI.
North American profile: Both markets. Essity Hygiene and Health AB is registered in both the United States and Canada.