OSIM International Ltd
Perancangan dan pembuatan merek produk kesehatan gaya hidup terkemuka di Singapura, ...
Merek produk kesehatan gaya hidup terkemuka di Singapura yang merancang dan memproduksi kursi pijat, alat pijat mata, dan perangkat kesehatan.
- Type
- Manufacturer
- Location
- Singapore
- Founded
- 1980
- Website
- osim.com
- Categories
- Perlengkapan Medis & Kesehatan, Peralatan Rumah Tangga
- Markets
- Singapura, Tiongkok, Taiwan, Hong Kong DAK Tiongkok, Malaysia
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)