FDA Registration
Active
🇰🇷 South Korea
MediThinQ Co., Ltd.
Reg #: 3015168749
·
FEI: 3015168749
·
Expires 2026
Products
4
Proprietary Names
45
Establishment Types
4
Classifications
4
Registration Details
- Registration Name
- MediThinQ Co., Ltd.
- Registration Number
- 3015168749
- FEI Number
- 3015168749
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 35 Pangyo-ro, 255beon-gil, Bundang-gu
- City
- Seongnam Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- MediThinQ Co., Ltd.
- Operator Number
- 10059499
- Address
- 35 Pangyo-ro, 255beon-gil, Bundang-gu
- City
- Seongnam
- State
- Gyeonggi
- Postal Code
- 13486
- Country
- KR
- Correspondent
- Seung Joon Im
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2019-01-29 |
| Drape, Microscope, Ophthalmic | HMW | Class 2 | General, Plastic Surgery | No | 2025-04-02 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2021-01-13 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2022-02-15 |
Proprietary Names
GV-CX1
GV-200C3
GV-200C2
GV-200D
GV-CX3
SE-TXC3
GV-P1
SE-EUD
SE-Hub
ScopEYE Wireless
GV-200C1
ScopEYE Wired
GV-200 Main Unit
SE-P1
GV-200 Smart Glasses
GV-100
GV-200MDT
SE-TXC2
GV-CX2
SE-EUDU
ScopEYE U
SE-TXC1
SE-TXD
SE-ED
SCOPEYE C (SE-C)
SE-MP
SE-EDN
SE-EUDN
SE-EDNH
SE-RX3
SE-TXMD
SE-EDF
Drape for SHIYA (SHIYA-ACD01)
MV-ACD01
SE-TX
SHIYA (SHIYA20)
METASCOPE (MS-1, MS-2)
SCOPEYE 3D MICROVISION (SE-MV)
BiLumix (BL-1, BL-2)
METASCOPE CAM (MS-C1, MS-C2)
3D METASCOPE (3DMS-1)
3D METASCOPE (3DMS-2)
SHIYA (SHIYA20-P)
SCOPEYE 3D MICROVISION S (SE-MVS)
SCOPEYE 3D ADDON (SE-AO)
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198