No Certificate Found

Snapshot 2026-10-09 · Link to EUDAMED

BrailleOne

UDI-DI 18306110000404Basic UDI-DI 83061100002JB

Class I · MDR · Technologies HumanWare Inc.

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Identification

Model: Digital talking book
EMDN: Y210999
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

Technologies HumanWare Inc.

SRN CA-MF-000022852

CA · Drummondville

manufacturer

Authorised representative: CEpartner4U (NL-AR-000000111)

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CE_DE-DE STRATUS 2_MDR 18306110001289
CE_DK-DA STRATUS 2_MDR 18306110001272
CE_ES-ES STRATUS 2_MDR 18306110001296
CE_FI-FI STRATUS 2_MDR 18306110001302
CE-FRFR_ PGI Connect 12_V2.1 w/ distance camera SL10_MDR 18306110000947
CE-FRFR_ PGI Connect 12_V2.1 w/ distance camera SL25_MDR 18306110000954
CE_FR-FR STRATUS 2_MDR 18306110001319
CE_IT-IT STRATUS 2_MDR 18306110001326
CE_NB-NO STRATUS 2_MDR 18306110001333

Showing 12 of 126 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/brailleone-0404 · UDI page: /udi/18306110000404

All devices from Technologies HumanWare Inc.

Scan an inventory CSV