FDA Device Establishments · JSON-LD · Markdown
FEI 3004832480 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3004832480 |
|---|---|
| Owner / Operator | SUPERCOMAL MEDICAL PRODUCTS, SDN BHD (#9065891) |
| Address | LOT 171,JALAN PKNK 3/8,KAWASAN, PERUSAHAAN, SUNGAI PETANI, SUNGAI PETANI Kedah, 08000, MY |
| Mandatory US Agent | BENTLEY BIOMEDICAL CONSULTING, LLC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | DXN, DSB |
| Regulation § (21 CFR) | 870.1130, 870.2770 |
| Proprietary names | EV1000 Clinical Platform With ClearSight Finger Cuff Or ClearSight System, EV1000 Clinical Platform |
Source: openFDA. Public-domain (CC0).