FDA Registration
Active
🇰🇷 South Korea
Insulin syringe
Reg #: 3013160284
·
FEI: 3013160284
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sungshim Medicare Co.,Ltd.
- Registration Number
- 3013160284
- FEI Number
- 3013160284
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 81, Seomi-ro, Seoun-myeon
- City
- Anseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K152803
Owner / Operator
- Firm Name
- Sungshim Medicare Co.,Ltd.
- Operator Number
- 10052486
- Address
- 81, Seomi-ro, Seoun-myeon
- City
- Anseong-si
- State
- Gyeonggi
- Postal Code
- 17608
- Country
- KR
- Correspondent
- Kim Young Kwan
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
- 92620
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2016-08-04 |
Proprietary Names
Insulin syringe
Establishment Types
Manufacture Medical Device