FDA Registration
Active
🇰🇷 South Korea
FINEMEDIX
Reg #: 3012042439
·
FEI: 3012042439
·
Expires 2026
Products
11
Proprietary Names
9
Establishment Types
1
Classifications
11
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Registration Details
- Registration Name
- FINEMEDIX
- Registration Number
- 3012042439
- FEI Number
- 3012042439
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 140-9, Yuram-ro, Dong-gu
- City
- Daegu Gwangyeogsi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K183289
Owner / Operator
- Firm Name
- FINEMEDIX CO., LTD.
- Operator Number
- 10056774
- Address
- 140-9, Yuram-ro, Dong-gu
- City
- Daegu Gwangyeogsi
- State
- KR-27
- Postal Code
- 41059
- Country
- KR
- Correspondent
- Heon-sik Lee
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 18881 Von Karman STE 160
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2018-01-15 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2019-04-06 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2024-10-16 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2018-11-02 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2019-01-03 |
| Snare, Non-Electrical | FGX | Class 1 | Gastroenterology, Urology | No | 2019-01-24 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2026-04-20 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2025-05-27 |
| Ligator, Esophageal | MND | Class 2 | Gastroenterology, Urology | No | 2020-10-13 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2020-10-13 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2020-10-13 |
Proprietary Names
Clear-Bite Biopsy Forceps
ClearGrasp Snare
ClearCap Distal Attachment
ClearTip
Clear-Jet Injection Catheter
ClearTip TBNA Type
ClearHemograsper
ClearEndoclip
ClearTip FNA and FNB Types
Establishment Types
Manufacture Medical Device