FDA Registration
Active
🇰🇷 South Korea
SMILELAB CO., LTD.
Reg #: 3013735968
·
FEI: 3013735968
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
10
Classifications
3
Registration Details
- Registration Name
- SMILELAB CO., LTD.
- Registration Number
- 3013735968
- FEI Number
- 3013735968
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- RB-106, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu,, Seongnam-si, Gyeonggi-do, Republic of Korea
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K150022
Owner / Operator
- Firm Name
- Smilelab Co., Ltd.
- Operator Number
- 10055410
- Address
- RB-106, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu,
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13211
- Country
- KR
- Correspondent
- YOUNGHUN SONG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2025-02-03 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2025-02-03 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2017-07-20 |
Proprietary Names
PREGABLE ovulation&pregnancy test kit (PREGABLE PREGNANCY TEST)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198
Sterilize Medical Device for Another Party (Contract Sterilizer)
Remanufacture Medical Device
Reprocess Single-Use Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility