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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Vr Stream2 - Netherlands/Dutch	95-STREAM2CE-NLNL	EUDAMED	Class I	Active
Vr Stream2 - Ukraine / Russian	95-STREAM2CE-UARU	EUDAMED	Class I	Active
DE_BI20 Brailliant_MDR	FGBR-1030	EUDAMED	Class I	Active
Multi-USEN Stream3	FGST-1100	EUDAMED	Class I	Active
Brailliant BI 20X	FGBR-1018	EUDAMED	Class I	Active
Vr Stratus 12m Germany/German	95-STRATUS12MCE-DEDE	EUDAMED	Class I	Active
Bn Touch 32 Bt + Eea	FGBT-1104	EUDAMED	Class I	Active
Multi-NLNL Stream3 603VRC_MDR	603VRC - FGST-1110	EUDAMED	Class I	Active
Vr Stratus 12i Wifi 423vr Ce-Fifi	FGSS-1058	EUDAMED	Class I	Active
Multi-AUEN Stream3 603VRC_MDR	FGST-1102	EUDAMED	Class I	Active
Vr Stratus 4m - France/French	95-STRATUS4MCE-FRFR	EUDAMED	Class I	Active
Multi-INHI Stream3 603VRC_MDR	FGST-1122	EUDAMED	Class I	Active
Vr Stratus 12 Sweden/Swedish	95-STRATUS12CE-SESV	EUDAMED	Class I	Active
Ce_pl-Pl Stratus 2_mdr	FGSS-1215	EUDAMED	Class I	Active
Vr Stratus 4i Wifi 422vr Ce-Sesv With Keycache	FGSS-1059	EUDAMED	Class I	Active
Vr Stream2 - Spain/Spanish	95-STREAM2CE-ESES	EUDAMED	Class I	Active
Vr Stratus4m Ce-Nono	FGSS-1075	EUDAMED	Class I	Active
Vr Stratus 4m With 64mb Ram-Sweden/Swedish	95-STRATUS4MMTMCE-SESV	EUDAMED	Class I	Active
Multi-DE_Q40 Mantis QWERTZ with GOV mode	FGBR-1106GOV	EUDAMED	Class I	Active
CE-FRFR_ PGI Connect 12_V2.1 w/ distance camera SL10_MDR	FGPG-1219SC	EUDAMED	Class I	Active
Multi-FOFO Stream3 603VRC_MDR	FGST-1123	EUDAMED	Class I	Active
Vr Stratus 12m United Kingdom/English	95-STRATUS12MCE-UKEN	EUDAMED	Class I	Active
Vr Stratus 4 - Norway/Norwegian	95-STRATUS4CE-NONO	EUDAMED	Class I	Active
Vr Stratus 12 Denmark/Danish	95-STRATUS12CE-DKDA	EUDAMED	Class I	Active
Ce_nb-No Stratus 2_mdr	FGSS-1212	EUDAMED	Class I	Active
Reveal 16i EEA	FGPG-1304	EUDAMED	Class I	Active
Multi-CAFR Stream3 603VRC_MDR	FGST-1104	EUDAMED	Class I	Active
Vr Stream2 Uk-Saar	FGST-1019	EUDAMED	Class I	Active
Explore 5	NOM-300 - FGEX1012	EUDAMED	Class I	Active
Multi-EN_BI40X Brailliant with GOV mode	FGBR-1017GOV	EUDAMED	Class I	Active
Vr Stream2 - United Kingdom/English	95-STREAM2CE-UKEN	EUDAMED	Class I	Active
Vr Stratus 12m Sweden/Swedish	95-STRATUS12MCE-SESV	EUDAMED	Class I	Active
Explore 5	NOM-301 - FGEX-1024	EUDAMED	Class I	Active
Vr Stratus 4m Ce With 64mb Ram-Sweden/Swedish With Wifi	FGSS-1057	EUDAMED	Class I	Active
Vr Stream2 - France/French	95-STREAM2CE-FRFR	EUDAMED	Class I	Active
Vr Stratus 4i Wi-Fi 422vr Ce-Fifi With Keycache	FGSS-1060	EUDAMED	Class I	Active
Vr Stratus12m Uk-Eses	FGSS-1078	EUDAMED	Class I	Active
Reveal 16 with XY Table	FGPG-1302	EUDAMED	Class I	Active
Vr Stratus 4m With 64mb Ram-Sweden/Swedish	95-STRATUS4MMMT-SESV	EUDAMED	Class I	Active
Vr Stratus 12 Netherlands/Dutch	95-STRATUS12CE-NLNL	EUDAMED	Class I	Active
Vr Stream2 (503vrc) Ce Russe	FGST-1017	EUDAMED	Class I	Active
Vr Stratus 12m Norway/Norwegian	95-STRATUS12MCE-NONO	EUDAMED	Class I	Active
Multi-HRHR Stream3 603VRC_MDR	FGST-1118	EUDAMED	Class I	Active
UKEN_ PGI C12_V2.1 upgrade_MDR	FGPG-1246	EUDAMED	Class I	Active
Vr Stream2 - Germany/German	95-STREAM2CE-DEDE	EUDAMED	Class I	Active
Vr Stratus 4m - Denmark/Danish	95-STRATUS4MCE-DKDA	EUDAMED	Class I	Active
Digital talking book	FGBR-1105GOV	EUDAMED	Class I	Active
Vr Stratus 4 - France/French	95-STRATUS4CE-FRFR	EUDAMED	Class I	Active
Connect 12 EN w/ camera x10	FGPG-1223	EUDAMED	Class I	Active
Ce_sv-Se Stratus 2_mdr	FGSS-1217	EUDAMED	Class I	Active

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