Manufacturer registered with FDA

Zhejiang Protect Medical Equipment Co. Ltd.

Anji, China. Lists 16 dental device types with FDA across 1 registered establishment.

FDA owner/operator10028005Manufacturer
Device types listed
16
Brands and models
32
510(k) clearances
0as applicant
Markets registered in
10629 registrations outside the US
Establishments
1China

Registered in 10 markets

Where regulators' registries name Zhejiang Protect Medical Equipment Co. Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 16 device types listedEuropean Union: 558 registrationsColombia: 29 registrationsSouth Korea: 17 registrationsTaiwan: 7 registrationsCosta Rica: 6 registrationsAustralia: 4 registrationsIsrael: 4 registrationsBrazil: 3 registrationsPeru: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerZhejiang Protect Medical Equipment Co. Ltd.16 device types—Below
European UnionEUDAMEDManufacturerZhejiang Protect Medical Equipment Co.,Ltd.558—Pure Global AI
ColombiaINVIMAManufacturerZHEJIANG PROTECT MEDICAL EQUIPMENT CO LTDZHEJIANG PROTECT MEDICAL EQUIPMENT CO., LTD.29—Pure Global AI
South KoreaMFDSManufacturerZhejiang Protect Medical Equipment Co.,Ltd.Zhejiang Protect Medical Equipment Co.,Ltd · Zhejiang Protect Medical Equipment Co., Ltd · +1172012–2023Pure Global AI
TaiwanTFDAManufacturerZHEJIANG PROTECT MEDICAL EQUIPMENT CO., LTD.72012–2026Pure Global AI
Costa RicaMinisterio de SaludManufacturerZHEJIANG PROTECT MEDICAL EQUIPMENT CO., LTD.6—Pure Global AI
AustraliaTGAManufacturerZhejiang Protect Medical Equipment Co Ltd42020–2022Pure Global AI
IsraelAMARManufacturerZhejiang Protect Medical Equipment Co LtdZhejiang Protect Medical Equipment Co. LTD · Zhejiang Protect Medical Equipment Co., Ltd · +14—Pure Global AI
BrazilANVISAManufacturerZhejiang Protect Medical Equipment Co. Ltd.ZHEJIANG PROTECT MEDICAL EQUIPMENT LTD32014–2016Pure Global AI
PeruDIGEMIDManufacturerZHEJIANG PROTECT MEDICAL EQUIPMENT CO., LTD.12014–2014Pure 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 Zhejiang Protect Medical Equipment Co. Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic Screw Expansion RetainerDYJ · Class 1Retainers, expanders & headgearMaker
eurodontoprotect
2010
Orthodontic Material BandDYO · Class 1Orthodontic wires & bandsMaker
eurodontoprotect
2010
Orthodontic Space Preformed MaintainerDYT · Class 1Retainers, expanders & headgearMaker
eurodontoprotect
2010
Orthodontic WireDZC · Class 1Orthodontic wires & bandsMaker
EurodontoProtect
2008
Orthodontic TubeDZD · Class 1Orthodontic wires & bandsMaker
EurodontoProtect
2008
Orthodontic Elastic BandECI · Class 1Orthodontic wires & bandsMaker
eurodontoprotect
2010
Orthodontic Preformed BandECM · Class 1Orthodontic wires & bandsMaker
EurodontoProtect
2008
Orthodontic Wire ClampECN · Class 1—Maker
EurodontoProtect
2008
Orthodontic SpringECO · Class 1Orthodontic wires & bandsMaker
EurodontoProtect
2008
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsMaker
eurodontoprotect
2010
Orthodontic Bracket AlignerECQ · Class 1Dental hand instrumentsMaker
EurodontoProtect
2010
Orthodontic Band SetterECR · Class 1Dental hand instrumentsMaker
eurodontoprotect
2010
Orthodontic Band PusherECS · Class 1Dental hand instrumentsMaker
eurodontoprotect
2010
Orthodontic Band DriverECT · Class 1Dental hand instrumentsMaker
eurodontoprotect
2010
Orthodontic Metal BracketEJF · Class 1Orthodontic bracketsMaker
EurodontoProtect
2008
Orthodontic PlierJEX · Class 1Dental hand instrumentsMaker
Eurodontoprotect
2010

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
ZHEJIANG PROTECT MEDICAL EQUIPMENT CO. LTD.FDA reg. 3007616048Anji Zhejiang, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10028005). 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.