FDA Device Establishments · JSON-LD · Markdown
FEI 3012084997 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3012084997 |
|---|---|
| Owner / Operator | GATE DENTAL SERVICES LTD ( T/A DentalOrganiser) (#10052726) |
| Address | Garrynagry, Roscahill, Galway, none, IE |
| Mandatory US Agent | Pragmatic Compliance dba FDAbasics |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EIG |
| Regulation § (21 CFR) | 872.4565 |
| Proprietary names | Spandex Advanced |
Source: openFDA. Public-domain (CC0).