Manufacturer registered with FDA

Ningbo Guangbo medical Technology co.,ltd

Ningbo, China. Lists 2 dental device types with FDA across 1 registered establishment.

FDA owner/operator10081109Manufacturer
Device types listed
2
Brands and models
2
510(k) clearances
0as applicant
Markets registered in
29 registrations outside the US
Establishments
1China

Registered in 2 markets

Where regulators' registries name Ningbo Guangbo medical Technology co.,ltd as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedEuropean Union: 9 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerNingbo Guangbo medical Technology co.,ltd2 device types—Below
European UnionEUDAMEDManufacturerNINGBO GUANGBO MEDICAL TECHNOLOGY CO.,LTD9—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 Ningbo Guangbo medical Technology co.,ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Roll CottonEFN · Class 1—Maker
Cotton Stick, Cotton Stick
2023
Dental FlossJES · Class 1Floss & interdental cleanersMaker
Floss, Dentat floss pick
2026

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
NINGBO GUANGBO MEDICAL TECHNOLOGY CO.,LTDFDA reg. 3015069920Ningbo Zhejiang, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10081109). 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.