FDA Registration
Active
🇰🇷 South Korea
STANPAD(STANPAD 0401, STANPAD 1001, STANPAD 1010, STANPAD 7538, STANPAD 81001, STANPAD 81010, STANPAD 80505)
Reg #: 3021389253
·
FEI: 3021389253
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
4
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 |
|---|---|---|---|---|---|
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2022-01-04 |
Proprietary Names
STANPAD(STANPAD 0401, STANPAD 1001, STANPAD 1010, STANPAD 7538, STANPAD 81001, STANPAD 81010, STANPAD 80505)
STANPAD(STANPAD P1040, STANPAD 51010, STANPAD 10505, STANPAD 75300)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198