Establishment registration
BIOTEM CO., LTD.
FDA establishment registration 3009611645 · Busan, KR
Key facts
| Registration number | 3009611645 |
|---|---|
| Establishment name | BIOTEM CO., LTD. |
| Owner/operator | Biotem Co., Ltd. |
| Owner/operator number | 10057313 |
| FEI number | 3009611645 |
| Address | # 422, Sasang-ro, Sasang-gu |
| City | Busan |
| Country | KR |
| Registration valid through | 2026 |
| Product codes listed | DZA, DZE, EBL, EIL, NDP, NHA |
| Device classes | 1, 2 |
At a glance
- 10–99 Device listings
- 1,000+ UDI devices (GUDID)
- Current Registration current
- None 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