Balkan Pharmaceuticals
Farmaceutische fabrikant die injecteerbare en orale medicijnformuleringen produceert voor Oost-Europese…
Farmaceutische fabrikant die injecteerbare en orale medicijnformuleringen produceert voor Oost-Europese en internationale groothandelsmarkten.
- Type
- Manufacturer
- Location
- Sofia, Bulgaria
- Founded
- 2006
- Website
- balkan-pharmaceuticals.com
- Categories
- Medische en gezondheidszorgbenodigdheden
- Markets
- Bulgarije, Roemenië, Moldavië, Oekraïne
Claimed certifications
- Good Manufacturing Practice
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)