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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Halo Vent Single IFAK, 1 Halo Vent, 5.5"x7.5" with CE Mark

UDI-DI 00850010608426Basic UDI-DI 08500106081216-10000NW

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

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

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