Balkan Pharmaceuticals
为东欧生产注射剂和口服药物制剂的制药商……
为东欧和国际批发市场生产注射剂和口服药物制剂的制药商。
- Type
- Manufacturer
- Location
- Sofia, Bulgaria
- Founded
- 2006
- Website
- balkan-pharmaceuticals.com
- Categories
- 医疗保健用品
- Markets
- 保加利亚, 罗马尼亚, 摩尔多瓦, 乌克兰
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)