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UDI Compass

HALO ONE

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 00801741161933Basic UDI-DI 0801741IAVNHCZXUR

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Class III · MDR · ClearStream Technologies Ltd

Identification

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

Certificates

2249575TD04

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2024-02-29 · Expiry 2029-02-01

Scope not stated in certificate data.

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

2249575CE04

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2024-02-29 · Expiry 2027-01-01

Scope not stated in certificate data.

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

Manufacturer

ClearStream Technologies Ltd

SRN IE-MF-000011725

IE · Enniscorthy, County Wexford

manufacturer

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Showing 12 of 26 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/halo-one-1933 · UDI page: /udi/00801741161933

All devices from ClearStream Technologies Ltd