FDA Registration
Active
🇰🇷 South Korea
SHINCHANG MEDICAL CO., LTD.
Reg #: 9616157
·
FEI: 3003169040
·
Expires 2026
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SHINCHANG MEDICAL CO., LTD.
- Registration Number
- 9616157
- FEI Number
- 3003169040
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 144, 1gongdan-ro 6-gil
- City
- Gumi-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 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2007-10-17 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2007-11-26 |
Proprietary Names
Profi Needle
Profi Pen Needle
Profi Syringe
DMject Insulin Syringe
SCM IV Catheter
Establishment Types
Manufacture Medical Device