Andon Health Co., Ltd.
Manufacturer and brand owner in Tianjin, China. 22 device types, 2 products catalogued, 101 clearances.
Andon Health Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Blood Pressure Cuff and 20 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
22device types registered with the FDA
2products catalogued under its own name
101510(k) clearances
Registration
| Registered name | ANDON HEALTH CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003741676 |
| FEI number | 3003741676 |
| DUNS | 421785478 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 天津九安医疗电子股份有限公司 |
|---|---|
| Source | EMIS company database |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | No. 3 Jin Ping Street,Ya An Road, |
| Postal code | 300190 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Arrigo Professional Supplies LLC | DXN | 2 |
| Arrigo Professional Supplies LLC | FLL | 1 |
Clearances
101 clearances name Andon Health Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251113 | 2025-08-04 | DXN | Abbreviated | This company |
| K241394 | 2024-12-20 | LCX | Traditional | This company |
| K234041 | 2024-04-22 | DXN | Abbreviated | This company |
| K222869 | 2023-02-15 | DXN | Abbreviated | This company |
| K222867 | 2022-12-21 | NUH | Abbreviated | This company |
| K212598 | 2022-01-28 | FLL | Abbreviated | This company |
| K210768 | 2021-07-30 | DXN | Abbreviated | This company |
| K210770 | 2021-07-29 | DXN | Abbreviated | This company |
| K202753 | 2021-03-08 | FLL | Traditional | This company |
| K202791 | 2021-01-05 | FLL | Abbreviated | This company |
| K201380 | 2020-10-07 | FXX | Abbreviated | This company |
| K200710 | 2020-10-01 | FLL | Abbreviated | This company |
| K200531 | 2020-07-15 | FLL | Traditional | This company |
| K183535 | 2019-06-04 | DXN | Traditional | This company |
| K183534 | 2019-05-16 | DXN | Abbreviated | This company |
| K181541 | 2019-04-16 | MWI | Traditional | This company |
| K181070 | 2019-02-01 | NBW | Traditional | This company |
| K172862 | 2018-07-24 | DSH | Traditional | This company |
| K170231 | 2017-09-15 | NBW | Traditional | This company |
| K171062 | 2017-08-01 | DXN | Abbreviated | This company |
| K171282 | 2017-07-27 | DXN | Abbreviated | This company |
| K163276 | 2017-05-11 | DXN | Abbreviated | This company |
| K153561 | 2017-02-16 | NBW | Traditional | This company |
| K162668 | 2017-02-14 | DXN | Abbreviated | This company |
| K162915 | 2017-02-08 | DXN | Abbreviated | This company |
| K162144 | 2017-02-01 | DXN | Abbreviated | This company |
| K153278 | 2016-08-19 | NBW | Traditional | This company |
| K153286 | 2016-08-19 | NBW | Traditional | This company |
| K160565 | 2016-08-10 | DXN | Abbreviated | This company |
| K160563 | 2016-08-04 | DXN | Abbreviated | This company |
| K160014 | 2016-02-02 | DXN | Special | This company |
| K150833 | 2015-12-04 | NBW | Traditional | This company |
| K152003 | 2015-09-24 | DXN | Special | This company |
| K152379 | 2015-09-23 | DXN | Special | This company |
| K151460 | 2015-09-08 | DXN | Special | This company |
| K150043 | 2015-08-14 | NUH | Traditional | This company |
| K141984 | 2015-04-29 | DXN | Traditional | This company |
| K140121 | 2014-07-02 | DXN | Special | This company |
| K133790 | 2014-05-22 | NBW | Special | This company |
| K133117 | 2014-03-04 | DXQ | Traditional | This company |
| K131111 | 2013-09-11 | DQA | Traditional | This company |
| K131203 | 2013-07-19 | DXN | Traditional | This company |
| K123935 | 2013-04-12 | NBW | Traditional | This company |
| K122098 | 2013-03-21 | DXN | Traditional | This company |
| K120813 | 2012-12-07 | NBW | Traditional | This company |
| K121697 | 2012-10-15 | DQA | Traditional | This company |
| K121372 | 2012-09-10 | DXN | Special | This company |
| K120896 | 2012-07-26 | MNW | Traditional | This company |
| K121470 | 2012-06-14 | DXN | Special | This company |
| K120672 | 2012-06-01 | DXN | Special | This company |
| K110017 | 2012-01-18 | NBW | Traditional | This company |
| K111830 | 2011-12-09 | DXN | Special | This company |
| K111826 | 2011-12-09 | DXN | Special | This company |
| K112738 | 2011-09-30 | NBW | Special | This company |
| K102678 | 2011-08-26 | NBW | Traditional | This company |
| K101307 | 2011-08-09 | NBW | Traditional | This company |
| K093755 | 2011-07-15 | NBW | Traditional | This company |
| K110328 | 2011-07-15 | DPS | Traditional | This company |
| K110018 | 2011-03-15 | DXN | Special | This company |
| K102939 | 2011-02-23 | DXN | Special | This company |
| K110330 | 2011-02-18 | DXN | Special | This company |
| K102609 | 2010-12-09 | DXN | Abbreviated | This company |
| K102690 | 2010-11-24 | DXN | Special | This company |
| K102631 | 2010-11-04 | DXN | Special | This company |
| K102930 | 2010-11-03 | DXN | Special | This company |
| K102906 | 2010-10-29 | DXN | Special | This company |
| K102356 | 2010-09-20 | DXN | Special | This company |
| K102353 | 2010-09-17 | DXN | Special | This company |
| K101950 | 2010-08-31 | DXN | Special | This company |
| K101010 | 2010-07-30 | DXN | Special | This company |
| K093262 | 2010-07-13 | NBW | Traditional | This company |
| K100940 | 2010-06-29 | DXN | Abbreviated | This company |
| K100014 | 2010-01-29 | DXN | Special | This company |
| K092811 | 2010-01-13 | DXN | Special | This company |
| K092588 | 2009-12-29 | DXN | Special | This company |
| K092510 | 2009-12-23 | DXN | Special | This company |
| K093452 | 2009-12-23 | DXN | Special | This company |
| K093528 | 2009-12-04 | DXN | Special | This company |
| K093387 | 2009-11-27 | DXN | Special | This company |
| K091739 | 2009-08-18 | DXN | Special | This company |
| K091738 | 2009-08-18 | DXN | Special | This company |
| K091737 | 2009-08-18 | DXN | Special | This company |
| K091500 | 2009-07-31 | DXN | Special | This company |
| K092045 | 2009-07-30 | DXN | Special | This company |
| K091997 | 2009-07-30 | DXN | Special | This company |
| K090769 | 2009-06-04 | DXN | Special | This company |
| K090771 | 2009-06-04 | DXN | Special | This company |
| K090772 | 2009-06-04 | DXN | Special | This company |
| K090770 | 2009-06-04 | DXN | Special | This company |
| K090768 | 2009-06-04 | DXN | Special | This company |
| K090963 | 2009-04-30 | DXN | Special | This company |
| K083395 | 2009-02-27 | DXN | Special | This company |
| K083318 | 2009-01-29 | DXN | Special | This company |
| K083247 | 2009-01-29 | DXN | Special | This company |
| K083248 | 2009-01-29 | DXN | Special | This company |
| K083319 | 2009-01-29 | DXN | Special | This company |
| K083246 | 2009-01-29 | DXN | Special | This company |
| K083317 | 2009-01-29 | DXN | Special | This company |
| K080326 | 2008-07-31 | DXN | Traditional | This company |
| K073030 | 2008-07-21 | NBW | Traditional | This company |
| K251085 | 2025-12-12 | SCA | Traditional | iHealth Labs, Inc. |
| K233842 | 2024-05-31 | QYT | Traditional | iHealth Labs, Inc. |
| K222034 | 2022-09-07 | QRL | Traditional | Beijing Ruicheng Medical Supplies Co., Ltd. |
Showing 103 of 104.
Nearby Manufacturers
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.