FDA Registration
Active
🇰🇷 South Korea
VPIX MEDICAL, INC.
Reg #: 3021744379
·
FEI: 3021744379
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- VPIX MEDICAL, INC.
- Registration Number
- 3021744379
- FEI Number
- 3021744379
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 774, Gyeryong-ro
- City
- Jung-gu Daejeon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K233391
Owner / Operator
- Firm Name
- VPIX Medical, Inc.
- Operator Number
- 10084429
- Address
- 774, Gyeryong-ro
- City
- Jung-gu
- State
- Daejeon
- Postal Code
- 34873
- Country
- KR
- Correspondent
- Kyungmin Hwang
US Agent
- Business Name
- KMC USA, Inc
- Contact Name
- Jung Ryun Ahn
- Address
- 115 East 34th street, 13J
- City
- New York
- State
- NY
- ZIP
- 10016
- Country
- US
- [email protected]
- Phone
- 646 3576058
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2024-08-28 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2024-08-28 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2026-04-07 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2025-02-12 |
| Microscope, Fluorescence/U.V. | IBK | Class 1 | Pathology | No | 2022-02-21 |
| Stains, Dye Solution | LEE | Class 1 | Hematology | No | 2024-08-28 |
| Stains, Dye Powder | LEF | Class 1 | Hematology | No | 2024-08-28 |
Proprietary Names
cCeLL - In vivo
cCeLL - In vivo with Drop-In Robo
VPIX Viewer
cCeLL - Ex vivo(Models: CX100-2W2C488775, CX100-1W1C405, CX100-1W1C488, CX100-1W1C775)
Topi - FNa
Topi - ICG
Establishment Types
Manufacture Medical Device