FDA Registration
Active
🇰🇷 South Korea
Medifine Pen Needle Quinta 5 Bevel
Reg #: 3011676762
·
FEI: 3011676762
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Tae-Chang Industrial Co., Ltd.
- Registration Number
- 3011676762
- FEI Number
- 3011676762
- Status
- Active
- Expiry Year
- 2025
- 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
- 18881 Von Karman Ave 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 |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-02-27 |
Proprietary Names
Medifine Pen Needle Quinta 5 Bevel
True plus
Trividia health
True plus Quinta tip
Insuflo
Medifine Pen Needle 3 Bevel
Insuflo Quinta
WGN TRUEplus 50CT 5 bevel Sterile pen needles
TRUEplus 5 bevel Sterile pen needles
TRUEplus 3 bevel Sterile pen needles
CVS TRUEplus 50CT 5 bevel Sterile pen needles
TRUEplus 50CT 5 bevel Sterile pen needles
Establishment Types
Manufacture Medical Device