Samsung Biologics
생물학적 제제 계약 개발 및 제조 서비스.
Samsung Biologics는 인천 사업장에서 생물학적 제제 계약 개발 및 제조 서비스를 제공합니다. 이 회사는 나열된 주요 시장 전반에 걸쳐 의료 시스템, 실험실, OEM 파트너 또는 규제 수출 고객에게 제품을 공급합니다.
- Type
- Manufacturer
- Location
- Incheon, South Korea
- Founded
- 2011
- Website
- samsungbiologics.com
- Categories
- 의료 및 건강 관리 용품
- Markets
- 대한민국, 미국, 독일, 싱가포르
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
Claimed certifications
- Good Manufacturing Practice
- 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)