Data / Medical devices / China / A&D Electronics (Shenzhen) Co., Ltd.
A&D Electronics (Shenzhen) Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 10 510(k) clearances
A&D Electronics (Shenzhen) Co., Ltd. is registered with the FDA (registration 3004128050) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 17, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004128050
- Address
- 1-5/F, Building #4, Hengchangrong High Tech Industry Park, Shangnan East Road Hongtian, Shajing, Bao'an District, Shenzhen Guangdong, China, 518125
- Owner or operator
- A&D Company, Limited (8031633)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 9, 2005
- Registered through
- 2027
- Brand names listed
- A&D Medical UB-543, A&D Medical UM-211 Digital Blood Pressure Monitor, Digital Blood Pressure Monitor, System, Measurement, Blood Pressure Non-invasive, UA-1020, UA-1020CEL, UA-1020CEL-CS, UA-1030T and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Contract manufacturer | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Contract manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| May 17, 2017 | K170196 | A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
| October 8, 2014 | K141201 | A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A & D Co., Ltd. | accessdata.fda.gov |
| October 7, 2014 | K141160 | A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A & D Co., Ltd. | accessdata.fda.gov |
| June 27, 2014 | K141179 | A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A & D Co., Ltd. | accessdata.fda.gov |
| August 1, 2011 | K111686 | A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
| January 19, 2007 | K062027 | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
| March 3, 2005 | K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
| December 3, 2004 | K042967 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
| October 30, 2003 | K032499 | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
| February 15, 2002 | K012472 | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | A&D Engineering, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Scale, Patient
- All makers of Blood Pressure Cuff
- All makers of Scale, Stand-On, Patient
Updated May 17, 2017. 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.