FDA Device Establishments · JSON-LD · Markdown
FEI 3013348547 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3013348547 |
|---|---|
| Owner / Operator | Cipher Surgical Ltd (#10060194) |
| Address | The Venture Centre, Sir William Lyons Road, Coventry, CV4 7EZ, GB |
| Mandatory US Agent | Medical Solutions Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | FEQ, OCX |
| Regulation § (21 CFR) | 876.1500 |
| Proprietary names | OpClear®; OpClear® Control Unit; OpClear® Disposable Procedure Kit; CS-CU15-03; OpClear® System; OpClear® Platform; OpClear® Disposable |
Source: openFDA. Public-domain (CC0).