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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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Organization name
UDI-DI code
Reference / catalog number

ISOL/8 — Class I MDR by Isol8 Healthcare Ltd

MD Atlas
Isol8 Healthcare Ltd

EUDAMED last updated this device on Jun 25, 2025

ISOL/8

0539154127IS8SMXG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Isol8 Healthcare Ltd
UDI-DI code: 05391541270294
Reference / catalog number: IS8RM02S

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Manufacturer information

Organization name: Isol8 Healthcare Ltd
SRN: IE-MF-000012420
Manufacturer status: Active

Related devices

ISOL/8539154127IS8MGBFOn the market ISOL/8539154127IS8MGBFOn the market ISOL/8B-05391541271734On the market ISOL/8B-05391541270188On the market ISOL/8B-05391541270041On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Device identification

Trade name: ISOL/8
UDI-DI code: 05391541270294
Basic UDI-DI: 0539154127IS8SMXG
Reference / catalog number: IS8RM02S
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 50
Additional product description: FLUIDSAFE Anti-Fog Surgical Mask - Type IIR surgical masks with anti-fog nose strip and surgical ties. Box of 50.
Additional information URL: https://www.isol8health.com/wp-content/uploads/2023/09/IFU-03-Type-IIR-Surgical-Masks-v003.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T020604MEDICAL USE FACE MASKS, TYPE II AND IIR

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
Manufacturing date
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Software identification