i-SENS
Системы мониторинга уровня глюкозы в крови и устройства для тестирования в местах оказания медицинской помощи.
i-SENS производит системы мониторинга уровня глюкозы в крови и устройства для тестирования в местах оказания медицинской помощи на своих предприятиях в Сеуле. Компания поставляет системы здравоохранения, лаборатории, OEM-партнерам или регулируемым экспортным клиентам на перечисленных основных рынках.
- Type
- brand seeking distribution
- Location
- Seoul, South Korea
- Founded
- 2000
- Website
- i-sens.com
- Categories
- Медицинские товары и расходники, Носимые устройства
- Markets
- Республика Корея, Соединенные Штаты, Германия, Япония
Verified facts
- domain-registered (green), checked 2026-08-08 Domain registry record
- web-presence-since (green), checked 2026-08-08 Internet Archive (Wayback)
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- fda-registered (green), checked 2026-08-08 FDA
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
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)