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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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Theatre Headwear — 30 UDI-DI variants, MDR (Isol8 Healthcare Ltd)

MD Atlas
Isol8 Healthcare Ltd

Data from EUDAMED, last updated May 24, 2026

Theatre Headwear

539154127IS8THC6

30 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: 539154127IS8THC6
Device name: Theatre Headwear
Device model: ISOL/8 Theatre Headwear (Comfort and Basics Ranges)
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jun 25, 2025

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

30 UDI-DI variants

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Applied filters

basicUdiUlid01JYKZNS82KRK1EFWZ8ACX4K8V

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/805391541272571
ISOL/805391541270355
ISOL/805391541270447
ISOL/805391541272854
ISOL/805391541270379
ISOL/805391541270416
ISOL/805391541270454
ISOL/805391541271062
ISOL/805391541272816
ISOL/805391541270423
ISOL/805391541272670
ISOL/805391541270393
ISOL/805391541272595
ISOL/805391541272793
ISOL/805391541272656
ISOL/805391541272717
ISOL/805391541272557
ISOL/805391541270386
ISOL/805391541270362
ISOL/805391541270430
ISOL/805391541272779
ISOL/805391541272878
ISOL/805391541272830
ISOL/805391541272618
ISOL/805391541272694

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