FDA Registration
Active
🇰🇷 South Korea
Tae-Chang Industrial Co., Ltd.
Reg #: 3011676762
·
FEI: 3011676762
·
Expires 2026
Products
1
Proprietary Names
14
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Tae-Chang Industrial Co., Ltd.
- Registration Number
- 3011676762
- FEI Number
- 3011676762
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 127, Sanho-daero
- City
- Gumi-si Gyeongbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K180720
Owner / Operator
- Firm Name
- Tae-Chang Industrial Co., Ltd.
- Operator Number
- 9062236
- Address
- 8-18, Bojeokdong-gil, Useong-myeon
- City
- Gongju-si
- State
- Chungnam
- Postal Code
- 32533
- Country
- KR
- Correspondent
- Jung-ryun In
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 |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2008-02-05 |
Proprietary Names
Exel Spinal Needles
True plus
True plus Quinta tip
Medifine Pen Needle 3 Bevel
Insuflo
Medifine Pen Needle Quinta 5 Bevel
Trividia health
Insuflo Quinta
TRUEplus 3 bevel Sterile pen needles
TRUEplus 5 bevel Sterile pen needles
CVS TRUEplus 50CT 5 bevel Sterile pen needles
WGN TRUEplus 50CT 5 bevel Sterile pen needles
TRUEplus 50CT 5 bevel Sterile pen needles
CAREFINE PEN NEEDLE
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device