FDA Registration
Active
🇰🇷 South Korea
UV-D Scanner Plus
Reg #: 3021736676
·
FEI: 3021736676
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SAEUM MEDITEC CO.
- Registration Number
- 3021736676
- FEI Number
- 3021736676
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 102-1406, 36, Bucheon-ro 198beon-gil
- City
- Bucheon-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K171007
Owner / Operator
- Firm Name
- Saeum Meditec Co.
- Operator Number
- 10084313
- Address
- 102-1406, 36, Bucheon-ro 198beon-gil
- City
- Bucheon-si
- State
- Gyeonggi
- Postal Code
- 14557
- Country
- KR
- Correspondent
- Ki W Lee
US Agent
- Business Name
- YTS Global Inc
- Contact Name
- Won Lee
- Address
- 7406 Alban Station Ct., A108
- City
- Springfield
- State
- VA
- ZIP
- 22150
- Country
- US
- [email protected]
- Phone
- 703 3408178
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laser, Fluorescence Caries Detection | NBL | Class 2 | Dental | No | 2023-09-11 |
Proprietary Names
UV-D Scanner Plus
Establishment Types
Manufacture Medical Device