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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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Surgical Face Mask — 8 UDI-DI variants, MDR (Isol8 Healthcare Ltd)

MD Atlas
Isol8 Healthcare Ltd

Data from EUDAMED, last updated May 24, 2026

Surgical Face Mask

0539154127IS8SMXG

8 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Isol8 Healthcare Ltd

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 0539154127IS8SMXG
Device name: Surgical Face Mask
Device model: FLUIDSAFE Surgical Mask
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: May 1, 2024

Manufacturer & authorised representative

Manufacturer

Name: Isol8 Healthcare Ltd
SRN: IE-MF-000012420
Country: Ireland
Email: info@isol8health.com
Phone: +353 667121659

Variants by status

UDI-DI variants

8 UDI-DI variants

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Applied filters

basicUdiUlid01HWRKNMMZ133M3Q8HNW4GVJVQ

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

ISOL/805391541270348
ISOL/805391541270300
ISOL/805391541270287
ISOL/805391541270034
ISOL/805391541270324
ISOL/805391541270331
ISOL/805391541270317
ISOL/805391541270294