Eliava BioPreparations
Bacteriophage preparation manufacturer
Georgian producer of therapeutic and prophylactic bacteriophage preparations for human, veterinary and environmental applications.
- Type
- Manufacturer
- Location
- Tbilisi, Georgia
- Founded
- 2008
- Website
- phage.ge
- Categories
- Medical & Healthcare Supplies, Chemicals & Plastics
- Markets
- Georgia
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)
- Chemical substances imported into the EU above 1 tonne/year must be REACH-registered. ECHA (REACH)