FDA Registration
Active
🇰🇷 South Korea
Fixone Instrument
Reg #: 3014232239
·
FEI: 3014232239
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Aju Medical Co., Ltd.
- Registration Number
- 3014232239
- FEI Number
- 3014232239
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- AJU Medical Co., Ltd.
- Operator Number
- 10056622
- Address
- Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13511
- Country
- KR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-12-26 |
Proprietary Names
Fixone Instrument
Genesis AWL
Genesis AWL/Tapper
Drill Guide
Awl
Dual Pitch Awl/Tapper
Drill Bit
Genesis Dual Pitch AWL/Tapper
Genesis Drill Guide
Awl/Tapper
Genesis Drill Bit
Establishment Types
Manufacture Medical Device