FDA Registration
Active
🇰🇷 South Korea
STERILE INSULIN PEN NEEDLE
Reg #: 3004458481
·
FEI: 3004458481
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHINA MED CORPORATION
- Registration Number
- 3004458481
- FEI Number
- 3004458481
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 455-30, Bogaewonsam-ro, Bogae-myeon
- City
- Anseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K113186
Owner / Operator
- Firm Name
- SHINA MED CORPORATION
- Operator Number
- 10048989
- Address
- 455-30, Bogaewonsam-ro, Bogae-myeon
- City
- Anseong-si
- State
- Gyeonggi
- Postal Code
- 17509
- Country
- KR
- Correspondent
- Kye Chae Jung
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 | 2016-02-19 |
Proprietary Names
STERILE INSULIN PEN NEEDLE
Establishment Types
Manufacture Medical Device