BIONOSTICS, INC.
Медицинские товары и расходники, Соединенные Штаты
BIONOSTICS, INC.: компания в сфере «Медицинские товары и расходники», Devens, Соединенные Штаты. Внесена в государственный реестр компаний.
- Type
- Manufacturer
- Location
- Devens, United States
- Categories
- Медицинские товары и расходники
Listed in a source registry
Verified facts
- facility-registered (green), checked 2026-08-03 US FDA device establishment registration (openFDA)
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)