FDA Registration
Active
🇰🇷 South Korea
YUNBIOTECH CO.,LTD.
Reg #: 3016444419
·
FEI: 3016444419
·
Expires 2026
Products
6
Proprietary Names
30
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- YUNBIOTECH CO.,LTD.
- Registration Number
- 3016444419
- FEI Number
- 3016444419
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 86, Namdongseo-ro
- City
- Namdong-gu Incheon
- Country
- KR
Owner / Operator
- Firm Name
- YUNbiotech Co.,Ltd.
- Operator Number
- 10062287
- Address
- 86, Namdongseo-ro
- City
- Namdong-gu
- State
- Incheon
- Postal Code
- 21697
- Country
- KR
US Agent
- Business Name
- J.S. CHEM INTERNATIONAL CO.
- Contact Name
- Grace Kim
- Address
- 20155 Pingree Way
- City
- Yorba Linda
- State
- CA
- ZIP
- 92887
- Country
- US
- [email protected]
- Phone
- 310 5983012
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2020-01-09 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2025-08-21 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2025-08-21 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2025-08-21 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2025-08-21 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2025-08-21 |
Proprietary Names
STARFIX, F-Fix Finger
G-Fix Ulnar Gutter
G-Fix Cock Up (Wrist)
STARFIX, F-Fix Hue
Bio Grab Finger
STARFIX, F-Fix Thumb 2
STARFIX, F-Fix Cock Up (Wrist)
STARFIX, F-Fix Functional
STARFIX, F-Fix Ulnar Gutter
Bio Grab Hand
G-Fix Cast Type
G-Fix Thumb
G-Fix Radial Gutter
STARFIX, F-Fix Cast Type
STARFIX, F-Fix Radial Gutter
Bio Grab Thumb
G-Fix Functional
STARFIX, F-Fix Thumb
STARFIX, F-Fix cylinder
STARFIX, F-Fix Long Leg
G-Fix Long Leg
Bio Grab Cylinder
G-Fix Cylinder
Cast Shoes
Bio Grab Hip Joint
G-Fix Long Arm
STARFIX, F-Fix Long arm
Bio Grab Short Leg (Ankle)
G-Fix Short Leg (Ankle)
STARFIX, F-Fix Short Leg (Ankle)
Establishment Types
Manufacture Medical Device