FRESENIUS KABI AUSTRIA GMBH
- Type
- Manufacturer
- Location
- GRAZ Steiermark, Austria
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- product-authorised-for-sale (green), checked 2026-08-20 NAFDAC Greenbook, Nigeria - register of authorised products (manufacturer named on the authorisation)
- public-contract-awarded (green), checked 2026-08-02 TED, EU public procurement bulletin Here the award carries someone else's check: in the EU and the EEA a public buyer must exclude bidders convicted of fraud, corruption or money laundering, and those found by a final decision to owe taxes or social contributions. Directive 2014/24/EU, Article 57 (exclusion grounds)
- operating-permit (green), checked 2026-08-19 EudraGMDP manufacturing authorisation register (EMA)
- debarment-clear (green), checked 2026-08-15 OpenSanctions
- sanctions-clear (green), checked 2026-08-15 OpenSanctions
- fda-registered (green), checked 2026-08-15 FDA
- fda-contract-manufacturer (green), checked 2026-08-15 FDA
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- aeo-certified (green), checked 2026-08-16 EU AEO register (European Commission)
- registered-manufacturer (green), checked 2026-08-18 Chemistry, Food and Drugs Division, Ministry of Health of Trinidad and Tobago, register of drugs (Food and Drugs Act Chap. 30:01)
- facility-registered (green), checked 2026-08-19 BPOM (Indonesian Food and Drug Authority), public register of manufacturing facilities behind product registrations (Sarana)
- gmp-certified (green), checked 2026-02-10 EudraGMDP, EU register of GMP certificates (EMA)
Claimed certifications
- Good Manufacturing Practice
- FDA Registered FDA Establishment Registration
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
- AEO, Authorised Economic Operator EU AEO database
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)