FDA Registration
Active
🇰🇷 South Korea
MANTIZ Co.,Ltd.
Reg #: 3021389253
·
FEI: 3021389253
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- MANTIZ Co.,Ltd.
- Registration Number
- 3021389253
- FEI Number
- 3021389253
- Status
- Active
- Expiry Year
- 2026
- 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
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 |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-12-27 |
| Silicone Hydrogel For Scar Management | PFP | Class 1 | General, Plastic Surgery | No | 2025-08-07 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2022-01-04 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2023-12-12 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2024-01-14 |
Proprietary Names
Luna Scar Gel
STANPAD(STANPAD P1040, STANPAD 51010, STANPAD 10505, STANPAD 75300)
STANPAD(STANPAD 0401, STANPAD 1001, STANPAD 1010, STANPAD 7538, STANPAD 81001, STANPAD 81010, STANPAD 80505)
STANFOAM(S2-7575-A10)
STANSEAL(S1-0000-C05)
STANCARE(J1-0000-A05)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device