FDA Device Establishments · JSON-LD · Markdown
FEI 3016629854 · Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3016629854 |
|---|---|
| Owner / Operator | HidraMed Solutions Limited (#10062420) |
| Address | Unit 209 Business Innovation Centre, NUI Galway, Galway, H91V207, IE |
| Mandatory US Agent | Willow Glen Consultancy LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MDR |
| Regulation § (21 CFR) | 880.5160 |
| Proprietary names | HidraWear BB GBB001_GBB002; HidraWear AX GAX001_GAX002 |
Source: openFDA. Public-domain (CC0).