FDA Device Establishments · JSON-LD · Markdown
FEI 3003708031 · Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3003708031 |
|---|---|
| Owner / Operator | CardioComm Solutions, Inc. (#9009563) |
| Address | 110 Sheppard Avenue East Suite 700, Suite 700, North York Ontario, M2N 6Y8, CA |
| Mandatory US Agent | AJW Technology Consultants, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DSH |
| Regulation § (21 CFR) | 870.2800 |
| Proprietary names | GEMS HL7; GEMS Win; GEMS Auto Attendant; GEMS Flex; GEMS Air |
Source: openFDA. Public-domain (CC0).