FDA Device Establishments · JSON-LD · Markdown
FEI 3014170143 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3014170143 |
|---|---|
| Owner / Operator | 3D Instrumentation Sdn Bhd (#10056829) |
| Address | No.95, Lorong IKS Juru 5, Taman Perindustrian Ringan Juru, Bukit Mertajam Pulau Pinang, 14000, MY |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HSB |
| Regulation § (21 CFR) | 888.3020 |
| Proprietary names | Slotted Mallet; Straight Ball Spike; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES; Tibia Drop; Tibia Nail Extraction Bolt |
Source: openFDA. Public-domain (CC0).