Establishment registration
Boston Scientific Medical Device (Malaysia) SDN BHD
FDA establishment registration 3014222368 · Taman Perindustrian Batu Kawan Pulau Pinang, MY
Key facts
| Registration number | 3014222368 |
|---|---|
| Establishment name | Boston Scientific Medical Device (Malaysia) SDN BHD |
| Owner/operator | Boston Scientific Corporation |
| Owner/operator number | 9912058 |
| FEI number | 3014222368 |
| Address | PMT 741, Persiaran Cassia Selatan 1 |
| City | Taman Perindustrian Batu Kawan Pulau Pinang |
| Country | MY |
| Registration valid through | 2026 |
| Product codes listed | DQX, FGE, GCA, GEX, LIT, LOX |
| Device classes | 2 |
At a glance
- 10–99 Device listings
- 100–999 UDI devices (GUDID)
- Current Registration current
- 1–9 FDA inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device establishment registrations
Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database