ORFIT INDUSTRIES NV
Orfit Industries | Leader in thermoplastics
As leaders in thermoplastic innovations we develop and produce precise and reliable thermoplastic materials for medical devices.
- Type
- Manufacturer
- Location
- WIJNEGEM Antwerpen, Belgium
- Website
- https://orfit.com
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- corporate-mail-on-domain (green), checked 2026-08-14 Mail server of the company domain
- fda-registered (green), checked 2026-08-14 FDA
- sanctions-clear (green), checked 2026-08-14 OpenSanctions
- debarment-clear (green), checked 2026-08-14 OpenSanctions
- domain-registered (green), checked 2026-08-14 Domain registry record
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
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)