Company profile
iSense Wonju Factory
KO: (주)아이센스원주공장
South Korea·강원도 원주시 문막읍 동화공단로 94-1·253 devices·Registered Jul 29, 2003 – Jan 02, 2024253
Total devices
3
Device classes
Jul 29, 2003
Earliest approval
Jan 02, 2024
Latest approval
Device class distribution
Breakdown of 253 devices by regulatory classification
Unknown
221
87.4% of total
Class I
19
7.5% of total
Class III
13
5.1% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
| Device Name | Class | License Number | Approval Date |
|---|---|---|---|
| Personal blood glucose test strip 개인용혈당검사지 | Unknown | In Vitro Drug No. 24-3 | Jan 02, 2024 |
| Personal blood glucose meter 개인용혈당측정기 | Unknown | In Vitro Drug No. 24-4 | Jan 02, 2024 |
| Personal blood glucose test strip 개인용혈당검사지 | Unknown | In Vitro No. 23-1170 | Dec 21, 2023 |
| Personal blood glucose meter 개인용혈당측정기 | Unknown | In Vitro Drug No. 23-1169 | Dec 21, 2023 |
| Personal blood glucose meter 개인용혈당측정기 | Unknown | In Vitro Drug No. 23-920 | Sep 13, 2023 |
| Personal blood glucose test strip 개인용혈당검사지 | Unknown | In Vitro No. 23-851 | Aug 22, 2023 |
| Personal blood glucose meter 개인용혈당측정기 | Unknown | In Vitro No. 23-76 | Feb 03, 2023 |
| Personal blood glucose meter 개인용혈당측정기 | Unknown | In Vitro No. 22-378 | Jun 10, 2022 |
| Personal blood glucose test strip 개인용혈당검사지 | Unknown | In Vitro No. 22-360 | May 31, 2022 |
| Blood glucose test strip for clinical examination 임상검사용혈당검사지 | Unknown | In Vitro Jane No. 22-4310 | Apr 20, 2022 |
About this profile
Complete regulatory portfolio for iSense Wonju Factory in South Korea's medical device market. This company has 253 medical devices registered with South Korea MFDS, with registrations dating from Jul 29, 2003 to Jan 02, 2024.
Browse the complete device portfolio including device classifications, license numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive South Korea MFDS registration data, helping global MedTech companies analyze market presence and regulatory compliance for medical device manufacturers in South Korea.
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