FDA Device Establishments · JSON-LD · Markdown
FEI 3003695829 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3003695829 |
|---|---|
| Owner / Operator | OnCore Manufacturing LLC (#10050743) |
| Address | 125 Fisher Street, Westborough, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OIZ |
| Regulation § (21 CFR) | 890.5050 |
| Proprietary names | Podimetrics Remote Temperature Monitoring System; SmartMat (SKU PMHS201U-R); Podimetrics Remanufactured SmartMat (SKU PMHS201U); SmartMat (SKU PMHS201U); Podimetrics Wi-Fi SmartMat (SKU PMHS230U); Podimetrics SmartMat+ (SKU PMHS300U) |
Source: openFDA. Public-domain (CC0).