TECAN AUSTRIA GMBH
- Type
- Manufacturer
- Location
- GROEDIG Salzburg, Austria
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- debarment-clear (green), checked 2026-08-15 OpenSanctions
- fda-registered (green), checked 2026-08-15 FDA
- fda-contract-manufacturer (green), checked 2026-08-15 FDA
- sanctions-clear (green), checked 2026-08-15 OpenSanctions
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
Claimed certifications
- FDA Registered FDA Establishment Registration
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
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)