Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003981912

FEI Number

3003981912

Entity Name

HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Bldg,2,Baimiao Ind.Park,, Economic Development Zone,Wuchang, Hangzhou Zhejiang 310023, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., (Owner Number: 9054972)

Owner / Operator Contact Address

Bldg,2,Baimiao Ind.Park,, Economic Development Zone,Wuchang, Hangzhou, CN-ZJ 310023, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FT-100E FT-100D FT-100A FT-100B Infrared ear thermometer( ET-100A/ET-100B/ ET-100D/ ET-100E/ ET-100G/ ET-100I/ ET-100J) Infrared forehead thermometer(FT-100A/FT-100B/FT-100D/FT-100E/FT-100I/ET-100EF) Digital thermometer( DTseries including DT-12A/DT-K111I/DT-K111J) JASUN JASUN

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	2016-08-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2010-01-27
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-07-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-16
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-12-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-16
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-02-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-12-02
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2022-09-28

Official Correspondent

Ahneo Yang

US Agent Details

Boyan Lu Email: vic520sky@gmail.com Phone: (914) 5368907

Related Public Records

Same Entity

HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,

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 3003981912. Last updated year: 2026. Please use registration number 3003981912 when referencing this establishment in official correspondence.