Seegene
Instruments de diagnostic moléculaire et tests de réactifs.
Seegene fabrique des instruments de diagnostic moléculaire et des tests de réactifs depuis ses opérations de Séoul. La société fournit des systèmes de santé, des laboratoires, des partenaires OEM ou des clients exportateurs réglementés sur ses principaux marchés cotés.
- Type
- brand seeking distribution
- Location
- Seoul, South Korea
- Founded
- 2000
- Website
- seegene.com
- Categories
- Fournitures médicales et de santé, Électronique grand public
- Markets
- Corée du Sud, États-Unis, Allemagne, Singapour
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- domain-registered (green), checked 2026-08-09 Domain registry record
- market-access-us (green), checked 2026-08-23 FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- fda-registered (green), checked 2026-08-09 FDA
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- 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)