FDA Device Establishments · JSON-LD · Markdown
FEI 3006895489 · Manufacture Medical Device · Status: Active
| FEI Number | 3006895489 |
|---|---|
| Owner / Operator | Medikro Oy (#10047101) |
| Address | Pioneerinkatu 3, Kuopio Pohjois-Savo, FI-70800, FI |
| Mandatory US Agent | Quality & Regulatory Services, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | BZG |
| Regulation § (21 CFR) | 868.1840 |
| Proprietary names | M975, Medikro Pro Spirometer Starter System; M9256-SP-90, Disposable Flow Transducer, single packed 90 pieces; M9256-50, Disposable Flow Transducer, 50 pieces; M985, Medikro Pro Spirometer with Starter Consumable Pack; M9264-200, Pressure Tube with connectors for Flow Transducer, length 200 cm; M9256-100, Disposable Flow Transducer, 100 pieces; M915, Medikro Pro Spirometer; 410370, PRESSURE TUBE & HANDLE, SPIRO; M9474, Calibration Syringe, volume 3000 ml; M984, Medikro Primo Spirometer with Starter Consumable Pack |
Source: openFDA. Public-domain (CC0).