Dental Device Guide
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Manufacturer registered with FDA

Berpu Medical Technology Co., Ltd.

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

FDA owner/operator9061974Manufacturer
Device types listed
1
Brands and models
2
510(k) clearances
0as applicant
Markets registered in
13167 registrations outside the US
Establishments
1China

Registered in 13 markets

Where regulators' registries name Berpu Medical Technology Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedBrazil: 40 registrationsUnited Kingdom: 31 registrationsPeru: 23 registrationsTaiwan: 14 registrationsCanada: 13 registrationsEuropean Union: 13 registrationsColombia: 8 registrationsSerbia: 8 registrationsAustralia: 7 registrationsSouth Korea: 5 registrationsCosta Rica: 4 registrationsHong Kong: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerBerpu Medical Technology Co., Ltd.1 device types—Below
BrazilANVISAManufacturerBERPU MEDICAL TECHNOLOGY CO., LTD402014–2026Pure Global AI
United KingdomMHRAManufacturerBERPU Medical Technology Co., Ltd31—Pure Global AI
PeruDIGEMIDManufacturerBERPU MEDICAL TECHNOLOGY CO., LTD.232019–2026Pure Global AI
TaiwanTFDAManufacturerBerpu Medical Technology Co., Ltd.142015–2024Pure Global AI
CanadaHealth CanadaRegistration holderBERPU MEDICAL TECHNOLOGY CO., LTD.132021–2025Pure Global AI
European UnionEUDAMEDManufacturerBerpu Medical Technology Co., Ltd13—Pure Global AI
ColombiaINVIMAManufacturerBERPU MEDICAL TECHNOLOGY CO., LTD.BERPU MEDICAL TECHNOLOGY CO.,LTD8—Pure Global AI
SerbiaALIMSManufacturerBerpu Medical Technology Co., Ltd.82023–2026Pure Global AI
AustraliaTGAManufacturerBerpu Medical Technology Co Ltd72018–2025Pure Global AI
South KoreaMFDSManufacturerBERPU Medical Technology Co.,LTD.BERPU MEDICAL TECHNOLOGY CO., LTD · BERPU MEDICAL TECHNOLOGY CO.,LTD.52019–2026Pure Global AI
Costa RicaMinisterio de SaludManufacturerBERPU MEDICAL TECHNOLOGY CO; LTD.4—Pure Global AI
Hong KongMDDManufacturerBerpu Medical Technology Co., Ltd.12026–2026Pure 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 Berpu Medical Technology 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 & syringesMaker
Sterile Dental Needles for Single UseSterile Irrigation Needle for Single Use
2020

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
Berpu Medical Technology Co., Ltd.FDA reg. 3004496829WENZHOU Zhejiang, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9061974). 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.