FDA Registration
Active
🇰🇷 South Korea
Profi Pen Needle
Reg #: 9616157
·
FEI: 3003169040
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHIN CHANG MEDICAL CO., LTD.
- Registration Number
- 9616157
- FEI Number
- 3003169040
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 144, 1 Gongdan-ro 6-gil
- City
- Guni-si Gyeongbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K070988
Owner / Operator
- Firm Name
- SHIN CHANG MEDICAL CO., LTD.
- Operator Number
- 9035332
- Address
- 320, GONGDAN-DONG, --
- City
- GUMI-CITY, GYEONG SANG BUK-DO
- State
- KR-NOTA
- Postal Code
- 730-030
- Country
- KR
- Correspondent
- Yushin - Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2007-10-17 |
Proprietary Names
Profi Pen Needle
Profi Needle
Establishment Types
Manufacture Medical Device