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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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STÉRIMAR — 3 UDI-DI variants, MDR (Sofibel)

MD Atlas
Sofibel

Data from EUDAMED, last updated May 19, 2026

STÉRIMAR

333130-STE-ISONIS-XY

3 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Sofibel

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 333130-STE-ISONIS-XY
Device name: STÉRIMAR
Device model: STÉRIMAR Isotonic Nasal Irrigation Solution Device Group
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Mar 11, 2026

Manufacturer & authorised representative

Manufacturer

Name: Sofibel
SRN: FR-MF-000003192
Country: France
Email: Audrey.Lucas@churchdwight.com

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01KKE634XSWE0YQ76DM4MXA3VA

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Sterimar Breathe Easy Daily05010724515068
Stérimar Nose Hygiene03331300097214
333130000641403331300006414