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Snapshot 2026-10-09 · Link to EUDAMED

ISOL/8

UDI-DI 05391541270034Basic UDI-DI 0539154127IS8SMXG

Class I · MDR · Isol8 Healthcare Ltd

Identification
Model
FLUIDSAFE Surgical Mask
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

No certificate found.

Snapshot 2026-10-09 · Link to EUDAMED

Manufacturer

Isol8 Healthcare Ltd

SRN IE-MF-000012420

IE · Ballincollig, Co. Cork

manufacturer

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Canonical device page: /device/isol-8-0034 · UDI page: /udi/05391541270034

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