FDA Device Establishments · JSON-LD · Markdown
FEI 3003782610 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3003782610 |
|---|---|
| Owner / Operator | HOYA Corporation PENTAX Division (#8030235) |
| Address | 30-2 Okada, Aza-Shimomiyano, Tsukidate, KURIHARA-SHI Miyagi, 987-2203, JP |
| Mandatory US Agent | HOYA CORPORATION PENTAX DIVISION |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | FDS, PEA, FDF |
| Regulation § (21 CFR) | 876.1500 |
| Proprietary names | PENTAX Medical Air/Water feeding Valve OE-B12; PENTAX Medical Water Jet Channel Cleaning Adapter OE-C31; PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15; PENTAX Medical Video Upper GI Scope EG29- i20c; PENTAX Medical Keyboard EN OS-A115; PENTAX Medical Suction control valve OE-B13; PENTAX White Balance Adjuster (OS-A43); PENTAX Medical Video Processor EPK-i8020c; Pentax Video Colonoscope (EC38-i20cL); PENTAX Medical Cylinder Cleaning Adapter (OE-B16) |
Source: openFDA. Public-domain (CC0).