Dental Device Guide
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Manufacturer registered with FDA

Maxigen Biotech Inc

Guishan District, Taoyuan City, Taiwan. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9103060Contract manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
1144 registrations outside the US
Establishments
1Taiwan

Registered in 11 markets

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

All markets
United States: 1 device types listedEuropean Union: 22 registrationsSouth Korea: 5 registrationsAustralia: 4 registrationsBrazil: 4 registrationsIsrael: 3 registrationsEgypt: 2 registrationsCanada: 1 registrationsHong Kong: 1 registrationsPeru: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: TaiwanOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerMaxigen Biotech Inc1 device types—Below
European UnionEUDAMEDManufacturerMaxigen Biotech Inc.22—Pure Global AI
South KoreaMFDSManufacturerMaxigen Biotech Inc.52013–2022Pure Global AI
AustraliaTGAManufacturerMaxigen Biotech Inc42024–2026Pure Global AI
BrazilANVISAManufacturerMAXIGEN BIOTECH INC.42026–2026Pure Global AI
IsraelAMARManufacturerMaxigen Biotech Inc.MAXIGEN BIOTECH, INC3—Pure Global AI
EgyptEDAManufacturerMaxigen Biotech Inc.,22023–2026Pure Global AI
CanadaHealth CanadaRegistration holderMAXIGEN BIOTECH INC.12026–2026Pure Global AI
Hong KongMDDManufacturerMaxigen Biotech Inc.12025–2025Pure Global AI
PeruDIGEMIDManufacturerMAXIGEN BIOTECH INC.12024–2024Pure Global AI
United KingdomMHRAManufacturerMaxigen Biotech Inc.1—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 Maxigen Biotech Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Animal Source Bone Grafting MaterialNPM · Class 2Bone grafts & membranesMaker
bone grafting material, animal source
2016

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
MAXIGEN BIOTECH, INC.FDA reg. 3004146122Taoyuan City, TaiwanContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9103060). 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.