FDA Registration
Active
🇰🇷 South Korea
MEDICAPS CO., LTD.
Reg #: 3026391023
·
FEI: 3026391023
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- MEDICAPS CO., LTD.
- Registration Number
- 3026391023
- FEI Number
- 3026391023
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 202-ho, New Seonkyung Plaza,, 13 Imae-ro, Bundang-gu,
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K042293
Owner / Operator
- Firm Name
- Medicaps Co., Ltd
- Operator Number
- 10092335
- Address
- 10, Bundang-ro 53beon-gil, Bundang-gu,
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13591
- Country
- KR
- Correspondent
- Kenny Kim
US Agent
- Business Name
- Block Imaging Parts and Service
- Contact Name
- Grace Lyon
- Address
- 1845 Cedar St
- City
- Holt
- State
- MI
- ZIP
- 48842
- Country
- US
- [email protected]
- Phone
- 517 6688800
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2025-01-02 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2024-12-24 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2026-03-01 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-07-08 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-07-08 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2025-07-08 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2025-06-20 |
Proprietary Names
Philips Brilliance CT
Parts for Brilliance iCT 256
GE Discovery 690 PET/CT
Philips Allura FD20
Siemens Artis Zee Cath Angio
GE Discovery MR750
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device