Manufacturer registered with FDA

Rizhao Sanqi Medical & Health Articles Co Ltd

Rizhao, China. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10044543Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
638 registrations outside the US
Establishments
1China

Registered in 6 markets

Where regulators' registries name Rizhao Sanqi Medical & Health Articles Co Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedAustralia: 15 registrationsEuropean Union: 10 registrationsColombia: 5 registrationsUnited Kingdom: 5 registrationsPeru: 3 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerRizhao Sanqi Medical & Health Articles Co Ltd1 device types—Below
AustraliaTGAManufacturerRizhao Sanqi Medical & Health Articles Co Ltd152020–2026Pure Global AI
European UnionEUDAMEDManufacturerRIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD.10—Pure Global AI
ColombiaINVIMAManufacturerRIZHAO SANQI MEDICAL & HEALTH ARTICLES CO. LTD.5—Pure Global AI
United KingdomMHRAManufacturerRizhao Sanqi Medical & Health Articles Co., Ltd.5—Pure Global AI
PeruDIGEMIDManufacturerRIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD.RIZHAO SANQI MEDICAL & HEALTH ARTICLES Co., Ltd.32022–2023Pure 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 Rizhao Sanqi Medical & Health Articles Co Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Paper Saliva AbsorberKHR · Class 1—Maker
Absorber, Saliva, Paper
2013

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
RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTDFDA reg. 3010374972Rizhao Shandong, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10044543). 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.