Dental Device Guide
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Manufacturer registered with FDA

Hygie Canada Inc.

Brossard, Canada. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10046551Foreign exporterManufacturerSpecification developer
Device types listed
1
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
512 registrations outside the US
Establishments
1Canada

Registered in 5 markets

Where regulators' registries name Hygie Canada Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedSerbia: 5 registrationsCanada: 3 registrationsEuropean Union: 2 registrationsUnited Kingdom: 2 registrations
RegisteredHome: CanadaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerHygie Canada Inc.1 device types—Below
SerbiaALIMSManufacturerHygie Canada Inc.52024–2024Pure Global AI
CanadaHealth CanadaRegistration holderHYGIE CANADA INC32023–2024Pure Global AI
European UnionEUDAMEDRegistration holderHygie Canada Inc2—Pure Global AI
United KingdomMHRAManufacturerHygie Canada Inc2—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Hygie Canada Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Tongue ScraperLCN · Class 1—Maker—2022

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
Hygie Canada Inc.FDA reg. 3008221237Drummondville Quebec, CanadaForeign exporter, Manufacturer, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10046551). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.