Data / Medical devices / Japan / A&D Manufacturing Company, Limited - Tsukuba Factory
A&D Manufacturing Company, Limited - Tsukuba Factory: FDA-registered device maker in Shimotsuma-shi Ibaraki, Japan, 3 510(k) clearances
A&D Manufacturing Company, Limited - Tsukuba Factory is registered with the FDA (registration 3006899423) in Shimotsuma-shi Ibaraki, Japan. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 24, 2019. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006899423
- Address
- 4210-15 Takasai, Shimotsuma-shi Ibaraki, Japan, 304-0031
- Owner or operator
- A&D Company, Limited (8031633)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 9, 2005
- Registered through
- 2027
- Brand names listed
- TM-2440 & TM-2441, TM-CF602D, TM-CF702D, UA-1020, UA-1030T, UA-606, UA-611, UA-651 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Scale, Patient | FRW | 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 |
|---|---|---|---|---|---|---|
| April 24, 2019 | K173065 | A&D Medical Blood Pressure Monitors | DXN | Substantially Equivalent | A&D Company, 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 |
| August 1, 2011 | K111686 | A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | A&D Company, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 24, 2019. 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.