FDA Device Establishments · JSON-LD · Markdown
FEI 3008264255 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3008264255 |
|---|---|
| Owner / Operator | RAUMEDIC Estonia AS (#10031831) |
| Address | Kadaka tee 46a, Tallinn Harjumaa, EE 12915, EE |
| Mandatory US Agent | Qserve Group US Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 10 |
| Product codes (top 20) | CBS, CCL, BZK, CAP, CBR, NHP, NHO, NHQ, CBQ, BZL |
| Regulation § (21 CFR) | 868.1620, 868.1720, 868.1850, 868.2600, 868.1700, 868.1500, 868.1730 |
| Proprietary names | D-Fend Water Trap, Black, 10/pkg; ADU Manual Bag Tube; Patient Spirometry Kit, Humid Conditions, 3m/10ft, 20/pkg; Disposable Spirometry Tube, Yellow, 2m/7ft, 5/pkg; Anesthesia Gas Sampling Line, Disposable, 2m/7ft, 100/pkg; Exhaust line, 2m/7ft; Anesthesia Gas Sampling Line, Disposable, 6m/20ft, 5/pkg; Disposable anestesia gas sampling line, OEM; Disposable CO2 Sampling Line, M/M Luer, 3m/10ft, 10/pkg; Anesthesia Gas Sampling Line Disp. M/M Elbow, 3m/10ft 10/pkg |
Source: openFDA. Public-domain (CC0).