KYURIUM BALGARIYA EOOD
Produttore farmaceutico bulgaro autorizzato dall'agenzia nazionale dei farmaci.
L'Agenzia bulgara dei farmaci elenca questa azienda nel suo registro delle autorizzazioni di produzione con l'autorizzazione BG/MIA-0567, rilasciata il 15-04-2026. L'autorizzazione riguarda i medicinali sterili. Nome registrato nel registro nazionale: КЮРИУМ БЪЛГАРИЯ ЕООД.
- Type
- Manufacturer
- Location
- Sofia, Bulgaria
- Categories
- Produzione farmaceutica, Forniture medicali e sanitarie
- Markets
- Bulgaria
Listed in a source registry
Bulgarian Drug Agency (ИАЛ), registers of manufacturers, importers and traders
Verified facts
- registered-manufacturer (green), checked 2026-08-20 Bulgarian Drug Agency (Изпълнителна агенция по лекарствата), register of manufacturing and import authorisations under art. 19 of the Medicinal Products Act
- operating-permit (green), checked 2026-08-20 Bulgarian Drug Agency (Изпълнителна агенция по лекарствата), register of manufacturing and import authorisations under art. 19 of the Medicinal Products Act
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)
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)