Data / Medical devices / China / Hangzhou Hua'an Medical & Health Instruments Co.
Hangzhou Hua'an Medical & Health Instruments Co.: FDA-registered device maker in Hangzhou Zhejiang, China, 10 510(k) clearances
Hangzhou Hua'an Medical & Health Instruments Co. is registered with the FDA (registration 3003981912) in Hangzhou Zhejiang, China. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 13, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003981912
- Address
- Bldg,2,Baimiao Ind.Park, Economic Development Zone,Wuchang, Hangzhou Zhejiang, China, 310023
- Owner or operator
- HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO. (9054972)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 16, 2007
- Registered through
- 2026
- Brand names listed
- Digital thermometer( DT-12A,DT-01ABDEG,DT-11ABDE,DT-101A111A101B111B,DT-K01AK11AK101AK111AK111IK111J), FT-100A, FT-100B, FT-100D, FT-100E, 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), JASUN
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2018 | K172870 | Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J | FLL | Substantially Equivalent | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | accessdata.fda.gov |
| December 19, 2017 | K172861 | Digital thermometer(with disposable thermometer cover) | FLL | Substantially Equivalent | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | accessdata.fda.gov |
| August 1, 2016 | K160999 | Infra-red forehead thermometer | FLL | Substantially Equivalent | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd | accessdata.fda.gov |
| November 7, 2012 | K122912 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) | FLL | Substantially Equivalent | Hangzhou Hua'An Medical & Health Instruments Co., | accessdata.fda.gov |
| January 7, 2010 | K092447 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES | FLL | Substantially Equivalent | Hangzhou Hua'An Medical & Health Instruments Co., | accessdata.fda.gov |
| December 4, 2009 | K092514 | UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES | DXN | Substantially Equivalent | Hangzhou Hua'An Medical & Health Instruments Co., | accessdata.fda.gov |
| December 2, 2004 | K041693 | WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES | DXN | Substantially Equivalent | Hangzhou Hua'An Medical & Health Instruments Co., | accessdata.fda.gov |
| September 13, 2004 | K041694 | DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER | FLL | Substantially Equivalent | Hangzhou Hua'An Medical & Health Instruments Co., | accessdata.fda.gov |
| September 13, 2004 | K041692 | INFRARED EAR THERMOMETER, ET-100 SERIES | FLL | Substantially Equivalent | Hangzhou Hua'An Medical & Health Instruments Co., | accessdata.fda.gov |
| February 21, 2003 | K030361 | JASUN, MODELS DT-01F AND DT-11F | FLL | Substantially Equivalent | Hangzhou Hua'An Medical & Health Instruments Co., | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Stethoscope, Manual
- All makers of Clinical Electronic Thermometer
Updated February 13, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.