Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

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

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

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/805391541272731
ISOL/805391541272755
ISOL/805391541272892
ISOL/805391541272632
ISOL/805391541270409

1 2