Dental Device Guide
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Manufacturer registered with FDA

Citotest Labware Manufacturing Co Ltd

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

FDA owner/operator9077486Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
11240 registrations outside the US
Establishments
1China

Registered in 11 markets

Where regulators' registries name Citotest Labware Manufacturing Co Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedUnited Kingdom: 73 registrationsEuropean Union: 62 registrationsSaudi Arabia: 45 registrationsSerbia: 21 registrationsBrazil: 14 registrationsTanzania: 10 registrationsAustralia: 5 registrationsColombia: 5 registrationsSouth Korea: 3 registrationsIsrael: 2 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerCitotest Labware Manufacturing Co Ltd1 device types—Below
United KingdomMHRAManufacturerCitotest Labware Manufacturing Co., Ltd.73—Pure Global AI
European UnionEUDAMEDManufacturerCITOTEST LABWARE MANUFACTURING CO.,LTD62—Pure Global AI
Saudi ArabiaSFDAManufacturerCITOTEST LABWARE MANUFACTURING CO.,LTD45—Pure Global AI
SerbiaALIMSManufacturerCITOTEST Labware Manufacturing Co., Ltd.212023–2025Pure Global AI
BrazilANVISAManufacturerCITOTEST LABWARE MANUFACTURING CO., LTD.142010–2020Pure Global AI
TanzaniaTMDAManufacturerCITOTEST LABWARE MANUFACTURING CO., LTD..Citotest Labware Manufacturing Co.,Ltd102022–2026Pure Global AI
AustraliaTGAManufacturerCitotest Labware Manufacturing Co Ltd52015–2021Pure Global AI
ColombiaINVIMAManufacturerCITOTEST LABWARE MANUFACTURING CO., LTD5—Pure Global AI
South KoreaMFDSManufacturerCITO TESTLABWARE MANUFACTURING CO., LTD.CITOTEST LABWARE MANUFACTURING CO., LTD · CITOTEST LABWARE MANUFACTURING CO.,LTD32014–2025Pure Global AI
IsraelAMARManufacturerCitotest Labware Manufacturing Co LtdCitotest Labware Manufacturing Co., Ltd.2—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 Citotest Labware Manufacturing Co Ltd 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
Tongue Scraper
2014

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
CITOTEST Labware Manufacturing CO., LTD.FDA reg. 3010420046Haimen Jiangsu, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9077486). 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.