FDA Device Establishments · JSON-LD · Markdown
FEI 3012521761 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3012521761 |
|---|---|
| Owner / Operator | Innovatif Cekal Sdn Bhd (#10061899) |
| Address | No 35, 37, 15 & 17 Jalan Haji Adbul Karim 53, Kampung Jawa, Klang Selangor, 41200, MY |
| Mandatory US Agent | Coloplast Corp. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | BYD |
| Regulation § (21 CFR) | 868.5375 |
| Proprietary names | TrachPhone |
Source: openFDA. Public-domain (CC0).