Altek Biotechnology Corporation
- Type
- brand seeking distribution
- Location
- Hsinchu Hsinchu (City), Taiwan
- Categories
- 医疗保健用品
Listed in a source registry
Verified facts
- registry-active-global (green), checked 2026-08-20 Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- registry-change-published (green), checked 2026-08-20 Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- officer-appointed (green), checked 2026-08-20 Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- ownership-on-record (green), checked 2026-08-20 Taiwan Ministry of Economic Affairs, Commerce Development Administration (經濟部商業發展署), company registration open data (GCIS)
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- debarment-clear (green), checked 2026-09-02 OpenSanctions
- fda-registered (green), checked 2026-09-02 FDA
- fda-contract-manufacturer (green), checked 2026-09-02 FDA
- sanctions-clear (green), checked 2026-09-02 OpenSanctions
- registry-id-verified (green), checked 2026-08-14 Taiwan International Trade Administration, import/export firm registry (BOFT)
- export-registered (green), checked 2026-08-14 Taiwan International Trade Administration, import/export firm registry (BOFT)
- registry-activity (green), checked 2026-08-14 Taiwan Ministry of Finance, national business tax registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)