Hangzhou Hua’an Medical & Health Instruments Co.,

Manufacturer and brand owner in Hangzhou, Zhejiang, China. 4 device types, 8 products catalogued, 10 clearances.

Registry build 21.09.26

Hangzhou Hua’an Medical & Health Instruments Co., is a manufacturer holding a current FDA establishment registration. The registration covers Stethoscope, Manual, Clinical Electronic Thermometer and 2 other device types. 8 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2007.

4device types registered with the FDA
8products catalogued under its own name
10510(k) clearances

Registration

FDA registration record for Hangzhou Hua’an Medical & Health Instruments Co.,
Registered name HANGZHOU HUA’AN MEDICAL & HEALTH INSTRUMENTS CO.,
Status Registered
Registration expires 2026
Registration number 3003981912
FEI number 3003981912
DUNS 544611767
Establishment type Manufacturer, Exporter

Chinese Registration

Chinese company register details for Hangzhou Hua’an Medical & Health Instruments Co.,
Chinese legal name 杭州华安医疗保健用品有限公司
Unified social credit code 9133011025392755X1
Source export sales certificate, Zhejiang medical products administration

Location

Address of Hangzhou Hua’an Medical & Health Instruments Co.,
City Hangzhou
Province Zhejiang
Address Bldg,2,Baimiao Ind.Park,
Postal code 310023
Country China

What It Makes

Device types Hangzhou Hua’an Medical & Health Instruments Co., is registered to make
Device type Class Listed under the names Listed since Chinese makers
Clinical Electronic Thermometer Class 2 Digital thermometer( DT-12A,DT-01ABDEG,DT-11ABDE,DT-101A111A101B111B,DT-K01AK11AK101AK111AK111IK111J), 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) 2025 49
Continuous Measurement Thermometer Class 2 Jasun, FT-100D, FT-100E, FT-100A, FT-100B 2007 115
Stethoscope, Manual Class 1 Jasun 2022 64
System, Measurement, Blood-Pressure, Non-Invasive Class 2 2007 98

Own-Brand Listings

Devices catalogued by Hangzhou Hua’an Medical & Health Instruments Co.,
Product Code Catalogue numbers
Essef FLL 9
IIF FLL 5
Rexall FLL 5
Jasun FLL 3
IIF DXN 2
femometer FLL 1
MY Medic FLL 1
Marathon Health FLL 1

Clearances

510(k) clearances naming Hangzhou Hua’an Medical & Health Instruments Co., or its listings
Clearance Decision date Product code Route Held by
K172870 2018-02-13 FLL Special This company
K172861 2017-12-19 FLL Special This company
K160999 2016-08-01 FLL Traditional This company
K122912 2012-11-07 FLL Special This company
K092447 2010-01-07 FLL Traditional This company
K092514 2009-12-04 DXN Traditional This company
K041693 2004-12-02 DXN Traditional This company
K041692 2004-09-13 FLL Traditional This company
K041694 2004-09-13 FLL Traditional This company
K030361 2003-02-21 FLL Traditional This company

From the Company

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

Information published by Hangzhou Hua’an Medical & Health Instruments Co.,
Founded 1997
Employees 180
Factory area 11,000 square meters
Main products digital clinical thermometers, digital infrared ear thermometers, digital infrared forehead thermometers, blood pressure monitors, stethoscopes
Certifications CE, MDR, ISO13485:2003, FDA, BSCI, FSC, RoHS
Export markets 136+ countries
OEM and ODM Offered

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Other registered manufacturers in the same city
Manufacturer Device types
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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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer