Hangzhou Thales Medtech Co., Ltd.

Manufacturer and brand owner in Hangzhou, Zhejiang, China. 3 device types, 2 products catalogued, 1 clearance.

Registry build 21.09.26

Hangzhou Thales Medtech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Teeth, Porcelain, Powder, Porcelain and 1 other device type. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.

3device types registered with the FDA
2products catalogued under its own name
1510(k) clearance

Registration

FDA registration record for Hangzhou Thales Medtech Co., Ltd.
Registered name HANGZHOU THALES MEDTECH CO., LTD.
Status Registered
Registration expires 2026
Registration number 3023272670
FEI number 3023272670
DUNS 841846639
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Hangzhou Thales Medtech Co., Ltd.
Chinese legal name 杭州泰利斯医疗科技有限公司
Unified social credit code 91330100MA2KFXFKX2
Source NMPA UDI database

Location

Address of Hangzhou Thales Medtech Co., Ltd.
City Hangzhou
Province Zhejiang
Address 2-3rd Floors, Building 2, Shanjing Technology Center, No. 167 Yunzhan Road, Zhuantang Street, Xihu District
Postal code 310000
Country China

What It Makes

Device types Hangzhou Thales Medtech Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Powder, Porcelain Class 2 Additive Manufacturing Zirconia Customized Restoration 2024 33
Teeth, Artificial, Posterior With Metal Insert Class 1 Zirconia Restoration 2022 14
Teeth, Porcelain Class 2 Additive Manufacturing Zirconia Customized Restoration 2024 3

Own-Brand Listings

Devices catalogued by Hangzhou Thales Medtech Co., Ltd.
Product Code Catalogue numbers
Zrcoop ELL 4
Cerawhite ELJ 3

Clearances

510(k) clearances naming Hangzhou Thales Medtech Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K240586 2024-10-03 ELL Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Hangzhou Thales Medtech Co., Ltd.
Founded 2021
Employees 81
Factory area 10,000 square meters
Main products 3D printed zirconia dental crowns

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

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