Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008754120

FEI Number

3008754120

Entity Name

HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

298 Yunxi Road, Cangqian Street, Yuhang District, Hangzhou Zhejiang 311121, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Universal Electronic Co., Ltd. (Owner Number: 10034707)

Owner / Operator Contact Address

298 Yunxi Road, Cangqian Street, Yuhang District, Hangzhou, CN-ZJ 311121, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Renewed Energy, Digital Thermometer, 121811/11012340 Digital Thermometer, Multiple Models VDTS-100U,EDTS-100U,VDTS-100R,VDTS-100B GF-MT501, GF-MT502, GF-MT503, GF-MT504, GF-MT505, GF-MT506, GF-MT507, GF-MT508, GF-MT509 GF-MT101, GF-MT102, GF-MT103, GF-MT104, GF-MT105, GF-MT106, GF-MT107, GF-MT108, GF-MT109 GF-MT801, GF-MT802, GF-MT803 Infrared Thermometer Infrared Forehead Thermometer FT-100C FT-100A FT-100B Digital thermometer Clinical electronic thermometer Infrared ear thermometer, ET-100A, ET-100B, ET-100C, ET-100D, ET-100E Infrared forehead thermometer, FT-100A, FT-100B, FT-100C, FT-100D, FT-100E, FT-100F Infrared ear/forehead thermometer, EF-100A, EF-100B, EF-100C, EF-100D, EF-100E, EF-100F, EF-100G, EF-100H Infrared thermometer Clinical thermometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2010-12-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-08-25
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-07-21

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Hangzhou Universal Electronic Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008754120. Last updated year: 2026. Please use registration number 3008754120 when referencing this establishment in official correspondence.