FDA Device Establishments · JSON-LD · Markdown
FEI 3010838917 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3010838917 |
|---|---|
| Owner / Operator | SunMed Group Holdings, LLC dba AirLife (#10044795) |
| Address | Kuortaneenkatu 2, Helsinki Uusimaa, FIN-00510, FI |
| Mandatory US Agent | AirLife |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | DQA, DSA |
| Regulation § (21 CFR) | 870.2700, 870.2900 |
| Proprietary names | CABLE, TRANSDUCER AND ELECTRODE, PATIENT; Oximeter |
Source: openFDA. Public-domain (CC0).