CHANGSHA U DE TOPTECH ELECTRONIC TECHNOLOGY CO.,LTD

FDA Device Registration & Listing · Changsha Hunan, CN · Registration 3017676696

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017676696
FEI Number
3017676696
Entity Name
CHANGSHA U DE TOPTECH ELECTRONIC TECHNOLOGY CO.,LTD
City/State/Country
Changsha Hunan, CN
Establishment Address
Floor 8,Building B2, Lugu xin chang hai center, No. 627 Lugu Avenue, Yuelu district, Changsha Hunan 410006, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Changsha U De Toptech Electronic Technology Co.,Ltd (Owner Number: 10079160)
Owner / Operator Contact Address
Floor 8,Building B2, Lugu xin chang hai center, No. 627 Lugu Avenue, Yuelu district, Changsha, CN-HN 410006, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Alcohol Tester Alcohol Tester, breathalyzer, breath-alcohol test system, mouthpiece breath-alcohol test system breathalyzer Breath alcohol testing terminal mouthpiece Water Quality Tester Water Quality Analyzer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DJZ Devices, Breath Trapping, Alcohol Clinical Toxicology Class 1 862.3050 2020-11-21
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2025-11-19
BXA Analyzer, Gas, Water Vapor, Gaseous-Phase Anesthesiology Class 1 868.1975 2025-11-19

Official Correspondent

Liang Li

US Agent Details

Wilson chen Business: REPF America LLC Email: qagujdsvvt@outlook.com Phone: (719) 2013315

Related Public Records

Same Entity

Changsha U De Toptech Electronic Technology Co.,Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017676696. Last updated year: 2026. Please use registration number 3017676696 when referencing this establishment in official correspondence.
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