BIONOSTICS, INC.
Medical & Healthcare Supplies, United States
BIONOSTICS, INC. is a medical & healthcare supplies company based in Devens, United States. Listed in a public business registry.
- Type
- Manufacturer
- Location
- Devens, United States
- Categories
- चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ
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)