Seegene
Molecular diagnostics instruments and reagent assays.
Seegene manufactures molecular diagnostics instruments and reagent assays from its Seoul operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Seoul, South Korea
- Founded
- 2000
- Website
- seegene.com
- Categories
- Medical & Healthcare Supplies, Consumer Electronics
- Markets
- South Korea, United States, Germany, Singapore
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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)