Company profile
Siemens Healthineers Co., Ltd.
KO: 지멘스헬시니어스(주)
South Korea·서울특별시 서초구 서초대로74길 14 10층(서초동, 더에셋)·1,186 devices·Registered Dec 16, 1999 – Dec 28, 20231,186
Total devices
4
Device classes
Dec 16, 1999
Earliest approval
Dec 28, 2023
Latest approval
Device class distribution
Breakdown of 1,186 devices by regulatory classification
Unknown
1,052
88.7% of total
Class I
63
5.3% of total
Class II
49
4.1% of total
Class III
22
1.9% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
| Device Name | Class | License Number | Approval Date |
|---|---|---|---|
| Universal Ultrasound Imaging Device 범용 초음파 영상 진단장치 | Unknown | Suin 23-4944 | Dec 28, 2023 |
| HIV· HBV· HCV· HTLV serotype and subtype test reagent HIV·HBV·HCV·HTLV혈청형·아형검사시약 | Unknown | In Vitro Water No. 23-345 | Oct 26, 2023 |
| Universal Ultrasound Imaging Device 범용 초음파 영상 진단장치 | Unknown | Suin 23-4825 | Oct 26, 2023 |
| Universal Ultrasound Imaging Device 범용 초음파 영상 진단장치 | Unknown | Suin 23-4794 | Oct 10, 2023 |
| Medical Image Analysis Software 의료영상 분석 소프트웨어 | Unknown | Suin 23-4762 | Sep 14, 2023 |
| Other Clinical Chemistry Test Reagents II. 기타임상화학검사시약Ⅱ | Unknown | In Vitro Recipient No. 23-4671 | Jul 13, 2023 |
| Positioning catheter control device 위치조정카테터제어장치 | Unknown | Suhe 23-246 | Jun 26, 2023 |
| High-risk infection immunoassay reagent 고위험성감염체면역검사시약 | Unknown | In Vitro Water Permit No. 23-231 | Jun 08, 2023 |
| Mobile ultrasound imaging device 이동형초음파영상진단장치 | Unknown | Suin 23-4618 | Jun 08, 2023 |
| Clinical Chemical Enzyme Test Reagent 임상화학효소검사시약 | Unknown | Extracorporeal water seal 23-4615 | Jun 07, 2023 |
About this profile
Complete regulatory portfolio for Siemens Healthineers Co., Ltd. in South Korea's medical device market. This company has 1,186 medical devices registered with South Korea MFDS, with registrations dating from Dec 16, 1999 to Dec 28, 2023.
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.
Free DatabasePowered by Pure Global AIMFDS Official Data1,186 Devices