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UDI Compass

Halo Vent Single IFAK, 1 Halo Vent, 5.5"x7.5"

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

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Class IIb · MDR · Medical Devices Inc.

Identification

Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No

Certificates

28620178174

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2024-10-17 · Expiry 2029-06-05

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Medical Devices Inc.

SRN US-MF-000033022

US · Romulus

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

Related UDI-DIs

NameUDI-DICertificate
Halo Vent 2 Pack IFAK, 2 Halo Vents 5.5"x7.5"00850010608488
Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/halo-vent-single-ifak-1-halo-vent-5-5-x7-5-with-ce-mark-8426 · UDI page: /udi/00850010608426

All devices from Medical Devices Inc.