FDA Device Establishments · JSON-LD · Markdown
FEI 3008573045 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3008573045 |
|---|---|
| Owner / Operator | ANDON MEDICAL CO.,LTD (#10033742) |
| Address | NO.26 HANGYU ROAD, TIANJIN AIRPORT ECONOMIC AREA, TIANJIN , TIANJIN , 300381 , CHINA, Tianjin, 300381, CN |
| Mandatory US Agent | IHEALTH LABS, INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | SDV |
| Regulation § (21 CFR) | 880.2910 |
| Proprietary names | Infrared Digital No-Touch Thermometer (model:PT2L); iHealth (model: PT9L); iHealth (model: PT3); Infrared No-Touch Forehead Thermometer (model:PT9L); iHealth (model: PT2L); iHealth Infrared No-Touch Forehead Thermometer (model:PT9S); iHealth (model: PT1); iHealth (model: PT3SBT) |
Source: openFDA. Public-domain (CC0).