Novartis Pharmaceutical Manufacturing GmbH
- Type
- Manufacturer
- Location
- Langkampfen Tirol, Austria
- Categories
- चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ
Listed in a source registry
Verified facts
- lei-active (green), checked 2026-08-07 GLEIF global LEI register (golden copy)
- operating-permit (green), checked 2015-12-17 EEA Industrial Emissions Portal (IED), EU-wide permit register
- facility-registered (green), checked 2026-08-03 US FDA device establishment registration (openFDA)
- aeo-certified (green), checked 2026-08-07 EU AEO register (European Commission)
- gmp-certified (green), checked 2026-03-17 EudraGMDP, EU register of GMP certificates (EMA)
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)