FDA Registration
Active
🇰🇷 South Korea
SureFine Pen Needle
Reg #: 3020138744
·
FEI: 3020138744
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- W.L.MED CO., LTD.
- Registration Number
- 3020138744
- FEI Number
- 3020138744
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 246, Geumgwangosan-ro, Geumgwang-myeon
- City
- Anseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K152877
Owner / Operator
- Firm Name
- W.L.Med Co., Ltd.
- Operator Number
- 10082898
- Address
- 246, Geumgwangosan-ro, Geumgwang-myeon
- City
- Anseong-si
- State
- Gyeonggi
- Postal Code
- 17535
- Country
- KR
- Correspondent
- Young Chul Bang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-10-12 |
Proprietary Names
SureFine Pen Needle
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)