Seegene
Instrumentos de diagnóstico molecular y ensayos de reactivos.
Seegene fabrica instrumentos de diagnóstico molecular y ensayos de reactivos en sus operaciones de Seúl. La empresa suministra sistemas de atención médica, laboratorios, socios OEM o clientes de exportación regulados en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Seoul, South Korea
- Founded
- 2000
- Website
- seegene.com
- Categories
- Suministros médicos y sanitarios, Electrónica de consumo
- Markets
- Corea del Sur, Estados Unidos, Alemania, Singapur
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)