Registered with FDA

Shanghai Carelife International Trading Co. LTD

Jinqiao Pudong, China. Lists 3 dental device types with FDA across 1 registered establishment.

FDA owner/operator10035047Foreign exporter
Device types listed
3
Brands and models
4
510(k) clearances
0as applicant
Markets registered in
649 registrations outside the US
Establishments
1China

Registered in 6 markets

Where regulators' registries name Shanghai Carelife International Trading Co. LTD as the manufacturer or the registration holder of a device.

All markets
United States: 3 device types listedSaudi Arabia: 43 registrationsSouth Korea: 3 registrationsBrazil: 1 registrationsEgypt: 1 registrationsIsrael: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerShanghai Carelife International Trading Co. LTD3 device types—Below
Saudi ArabiaSFDAManufacturerShanghai Carelife International Trading Co., Ltd43—Pure Global AI
South KoreaMFDSManufacturerShanghai Carelife International Trading Co., Ltd.Shanghai Carelife International Trading Co., Ltd32012–2018Pure Global AI
BrazilANVISAManufacturerSHANGHAI CARE LIFE INTERNATIONAL TRADING CO. LTD.12011–2011Pure Global AI
EgyptEDAManufacturerShanghai Carelife International Trading Co. Ltd.,12024–2024Pure Global AI
IsraelAMARManufacturerShanghai Carelife International Trading Co., Ltd.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 Shanghai Carelife International Trading Co. LTD currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental NeedleDZM · Class 1Dental needles & syringesLister
PLASDENT
2013
Irrigating (Dental) SyringeEIB · Class 1Dental hand instrumentsLister—2016
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsLister
Plastic cleaning tipsPlastic tipsPlastic utility tubes
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
SHANGHAI CARELIFE INTERNATIONAL TRADING CO. LTDFDA reg. 3004143450Jinqiao Pudong Shanghai, ChinaForeign exporter

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10035047). 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.