Gloor Ltd.
- Type
- Manufacturer
- Location
- Burgdorf Bern, Switzerland
- Categories
- 의료 및 건강 관리 용품
Listed in a source registry
Verified facts
- lei-lapsed (amber), checked 2026-08-07 GLEIF global LEI register (golden copy)
- facility-registered (green), checked 2026-08-03 US FDA device establishment registration (openFDA)
- sanctions-clear (green), checked 2026-07-21 OpenSanctions
- fda-registered (green), checked 2026-07-21 FDA
- fda-contract-manufacturer (green), checked 2026-07-21 FDA
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)