Andon Medical co., Ltd
Tianjin, CN
Andon Medical co., LTD appears in FDA device records in Tianjin, CN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Andon Medical co., Ltd between 2010 and 2013. The busiest year on record is 2011, with 4. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123935 | IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K120813 | BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K110017 | AG-608N BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K112738 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE | NBW | Substantially Equivalent | |
| K102678 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS | NBW | Substantially Equivalent | |
| K101307 | BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 | NBW | Substantially Equivalent | |
| K093755 | AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K102609 | KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K093262 | AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008573045 | 3008573045 | Andon Medical co., LTD | NO.26 HANGYU ROAD, TIANJIN AIRPORT ECONOMIC AREA, Tianjin 300381 CN | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PUHAnalyzer, Body Composition, Exempt
- DXQBlood Pressure Cuff
- SDVClinical Electronic Thermometer
- QKPCoronavirus Antigen Detection Test System.
- QMNCovid-19 Multi-Analyte Antigen Device
- LFRGlucose Dehydrogenase, Glucose
- KMAIrrigator, Powered Nasal
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test
- QYTOver-The-Counter Covid-19 Antigen Test
- DQAOximeter
- OCHOximeter, Infrared, Sporting, Aviation
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- NBWSystem, Test, Blood Glucose, Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Andon Medical co., Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain