Manufacturer registered with FDA

Ziyang Freqty Medical Equipment Co., Ltd.

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

FDA owner/operator10082919Foreign exporterManufacturer
Device types listed
2
Brands and models
3
510(k) clearances
0as applicant
Markets registered in
1131 registrations outside the US
Establishments
1China

Registered in 11 markets

Where regulators' registries name Ziyang Freqty Medical Equipment Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedSerbia: 8 registrationsAustralia: 5 registrationsTaiwan: 5 registrationsPeru: 4 registrationsEuropean Union: 2 registrationsIsrael: 2 registrationsSouth Korea: 2 registrationsCanada: 1 registrationsCosta Rica: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerZiyang Freqty Medical Equipment Co., Ltd.2 device types—Below
SerbiaALIMSManufacturerZiyang Freqty Medical Equipment Co., Ltd.82023–2026Pure Global AI
AustraliaTGAManufacturerZiyang Freqty Medical Equipment Co Ltd52020–2025Pure Global AI
TaiwanTFDAManufacturerZiyang Freqty Medical Equipment Co., Ltd.Ziyang Freqty Medical Equipment Co.,Ltd52022–2025Pure Global AI
PeruDIGEMIDManufacturerZIYANG FREQTY MEDICAL EQUIPMENT CO., LTD.42022–2024Pure Global AI
European UnionEUDAMEDManufacturerZiyang Freqty Medical Equipment Co., Ltd.2—Pure Global AI
IsraelAMARManufacturerZiyang Freqty Medical Equipment Co., LtdZiyang Freqty Medical Equipment Co., Ltd.2—Pure Global AI
South KoreaMFDSManufacturerZiyang Freqty Medical Equipment Co., Ltd.22024–2025Pure Global AI
CanadaHealth CanadaRegistration holderZIYANG FREQTY MEDICAL EQUIPMENT CO., LTD.12025–2025Pure Global AI
Costa RicaMinisterio de SaludManufacturerZiyang Freqty Medical Equipment Co., Ltd1—Pure Global AI
United KingdomMHRAManufacturerZiyang Freqty Medical Equipment 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 Ziyang Freqty Medical Equipment Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
HAT 1 Scanbody, HAT 1 Lab Analog, HAT 1 Screwdriver, HAT 1 Scanning Kit
2026
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2Intraoral scannersMaker
Intraoral Digital Impression Instrument, PANDA P2,PANDA P2 Plus, PANDA P3, PANDA smart p, PANDA smart y, ELETRA SMARTPANDA free, PANDA P3 Plus, PIOS-EX5
2021

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
ZIYANG FREQTY MEDICAL EQUIPMENT CO., LTD.FDA reg. 3020984550Ziyang Sichuan, ChinaForeign exporter, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10082919). 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.