Baui Biotech Co., Ltd
Pianta certificata dall'ente regolatore sanitario brasiliano (ANVISA)
ANVISA, l'ente regolatore sanitario brasiliano, detiene un certificato di buona pratica di fabbricazione valido per questo impianto, che copre i dispositivi medici, valido fino al 02-09-2026. Il certificato viene rilasciato dopo un'ispezione dello stabilimento stesso, motivo per cui un regolatore straniero nomina questo sito: le merci prodotte qui sono ammesse sul mercato brasiliano. Il certificato registra l'indirizzo del sito come Nº 6 (6F), Nº 8 (6F, 9F), SEC. 1, ZHONGXING RD., DISTRETTO DI WUGU, NUOVA CITTÀ DI TAIPEI, 24872 - TAIWAN. Numero di processo 25351562714201571.
- Type
- brand seeking distribution
- Location
- Xinbei (New Taipei City), Taiwan
- Categories
- Forniture medicali e sanitarie
- Markets
- Taiwan, Brasile
Listed in a source registry
Verified facts
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- registry-id-verified (green), checked 2026-09-06 Taiwan International Trade Administration, import/export firm registry (BOFT)
- export-registered (green), checked 2026-09-06 Taiwan International Trade Administration, import/export firm registry (BOFT)
- facility-registered (green), checked 2026-09-06 Taiwan Industrial Development Administration, registered factory directory (status: producing)
- registry-activity (green), checked 2026-09-06 Taiwan Ministry of Finance, national business tax registration
- debarment-clear (green), checked 2026-08-31 OpenSanctions
- sanctions-clear (green), checked 2026-08-31 OpenSanctions
- fda-registered (green), checked 2026-08-31 FDA
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)