FDA Registration
Active
🇰🇷 South Korea
STANSEAL(S1-0000-C05)
Reg #: 3021389253
·
FEI: 3021389253
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- MANTIZ Co.,Ltd.
- Registration Number
- 3021389253
- FEI Number
- 3021389253
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 423-15, Hyeoksin-daero, Dong-gu
- City
- Daegu
- Country
- KR
Owner / Operator
- Firm Name
- MANTIZ Co.,Ltd.
- Operator Number
- 10083878
- Address
- 423-15, Hyeoksin-daero, Dong-gu
- City
- Daegu
- State
- KR-27
- Postal Code
- 41071
- Country
- KR
- Correspondent
- EUI JUN KIM
US Agent
- Business Name
- Withus Group Inc
- Contact Name
- April Lee
- Address
- 106 Superior
- City
- Irvine
- State
- CA
- ZIP
- 92620
- Country
- US
- [email protected]
- Phone
- 909 2749971
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2023-12-12 |
Proprietary Names
STANSEAL(S1-0000-C05)
STANFOAM(S2-7575-A10)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device