COSMADE BELGIUM BV
Company - Cosmade Belgium
Cosmade Belgium was founded in 2001 by engineer André Nagels, who by then already had 20 years of experience in the field of cosmetics and medical devices. The company was originally located in Reet. At the end of 2005, Cosmade Belgium has moved to a new location in Heist-op-den-Berg.
- Type
- Manufacturer
- Location
- Heist-op-den-Berg Antwerpen, Belgium
- Website
- https://cosmade.be
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- facility-registered (green), checked 2026-08-17 US FDA device establishment registration (openFDA)
- debarment-clear (green), checked 2026-08-14 OpenSanctions
- fda-registered (green), checked 2026-08-14 FDA
- corporate-mail-on-domain (green), checked 2026-08-14 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-14 OpenSanctions
- fda-contract-manufacturer (green), checked 2026-08-14 FDA
Claimed certifications
- FDA Registered FDA Establishment Registration
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)