OSIM International Ltd
싱가포르 최고의 라이프스타일 건강 제품 브랜드로 마사지 의자, 전자…
싱가포르 최고의 라이프스타일 건강 제품 브랜드로 안마 의자, 안구 마사지기, 건강 기기를 설계 및 제조하고 있습니다.
- Type
- Manufacturer
- Location
- Singapore
- Founded
- 1980
- Website
- osim.com
- Categories
- 의료 및 건강 관리 용품, 가전제품
- Markets
- 싱가포르, 중국, 대만, 홍콩(중국 특별행정구), 말레이시아
Verified facts
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- domain-registered (green), checked 2026-08-09 Domain registry record
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)
- Consumer goods sold in the EU fall under the General Product Safety Regulation (GPSR, applies since 13 Dec 2024): a responsible person in the EU is mandatory. EUR-Lex: Regulation (EU) 2023/988 (GPSR)