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Technologies HumanWare Inc.

Canada·CA-MF-000022852

Last updated September 18, 2026

About

HumanWare is the global leader in assistive technology and innovative products for people who are blind or have low vision.

From the manufacturer's own website. Source

What Technologies HumanWare Inc. makes

Technologies HumanWare Inc. manufactures a range of electronic reading devices, including refreshable Braille displays such as the Stratus series (with variants for different languages and regions), standalone Braille terminals like the Monarch and Explore 12, and portable Braille note-takers like the Mantis Q40. The company also produces software upgrades for existing devices, such as firmware updates for the PGI C12. Additional products include the Reveal 16, a refreshable Braille display designed for accessibility.

The company’s devices fall under Class I medical device classifications and are registered in the EUDAMED database. HumanWare Inc. is headquartered in Canada, with its products authorised for use in multiple European markets, including France, Norway, and the United Kingdom, where language-specific versions are available.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Canada
Address: 1800, Michaud, Drummondville, Canada
Website: www.humanware.com
LinkedIn: linkedin.com/company/humanware
Facebook: facebook.com/humanware
Email: [email protected]
Phone: +15147793855
PRRC Contact: Louis-Philippe Massé
EUDAMED SRN: CA-MF-000022852
FDA FEI Number: —
DUNS Number: —

Catalogue (132)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Multi-SESV Stream3 603VRC_MDR	FGST-1107	EUDAMED	Class I	Active
Vr Stratus 4 - Sweden/Swedish	95-STRATUS4CE-SESV	EUDAMED	Class I	Active
Vr Stratus 12m Netherlands/Dutch	95-STRATUS12MCE-NLNL	EUDAMED	Class I	Active
Multi-RURU Stream3 603VRC_MDR	FGST-1115	EUDAMED	Class I	Active
Vr Stream2 - Norway/Norwegian	95-STREAM2CE-NONO	EUDAMED	Class I	Active
Vr Stratus12m Dod Ce-Nlnl	FGSS-1077	EUDAMED	Class I	Active
Vr Stratus 4m - Netherlands/Dutch	95-STRATUS4MCE-NLNL	EUDAMED	Class I	Active
Multi-NBNO Stream3 603VRC	FGST-1117	EUDAMED	Class I	Active
Multi-ISIS Stream3 603VRC_MDR	FGST-1120	EUDAMED	Class I	Active
Vr Stratus 4m Wi-Fi 412vr Ce-Fifi	FGSS-1071	EUDAMED	Class I	Active
Multi-ESES Stream3 603VRC_MDR	FGST-1105	EUDAMED	Class I	Active
Connect 12 FR w/ camera x25	FGPG-1222	EUDAMED	Class I	Active
FRFR_ PGI Connect 12_V2.1_MDR	FGPG-1218SC	EUDAMED	Class I	Active
Vr Stratus 12i Wifi 423vr Ce-Sesv	FGSS-1048	EUDAMED	Class I	Active
Explore 8	NOM-400 - FGEX-1025	EUDAMED	Class I	Active
Vr Stratus 4m - Sweden/Swedish	95-STRATUS4MCE-SESV	EUDAMED	Class I	Active
Vr Stratus 4 - Netherlands/Dutch	95-STRATUS4CE-NLNL	EUDAMED	Class I	Active
UKEN_ PGI Connect 12_V2.1_MDR	FGPG-1205SC	EUDAMED	Class I	Active
Vr Stratus 4 - Denmark/Danish	95-STRATUS4CE-DKDA	EUDAMED	Class I	Active
Ce_es-Es Stratus 2_mdr	FGSS-1206	EUDAMED	Class I	Active
Vr Stratus4m Ce-Nlnl 412 Dod	FGSS-1076	EUDAMED	Class I	Active
Vr Stratus 4i 422vr Ce-Sesv	FGSS-1047	EUDAMED	Class I	Active
Vr Stratus 4m - Germany/German	95-STRATUS4MCE-DEDE	EUDAMED	Class I	Active
Vr Stratus 12m Dod Ce Ltlt - Avec Wifi	FGSS-1073	EUDAMED	Class I	Active
Multi-UKEN Stream3 603VRC_MDR	FGST-1101	EUDAMED	Class I	Active
Multi-DEDE Stream3 603VRC_MDR	FGST-1109	EUDAMED	Class I	Active
Ce_fr-Fr Stratus 2_mdr	FGSS-1210	EUDAMED	Class I	Active
Mantis Q40 QWERTZ	FGBR-1106	EUDAMED	Class I	Active
Ce_nl-Nl Stratus 2_mdr	FGSS-1214	EUDAMED	Class I	Active
Multi-PLPL Stream3 603VRC_MDR	FGST-1112	EUDAMED	Class I	Active
Vr Stratus 12m Dod Ce Uaru - Avec Wifi	FGSS-1072	EUDAMED	Class I	Active
Vr Stratus 4 - Germany/German	95-STRATUS4CE-DEDE	EUDAMED	Class I	Active

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