FDA Registration
Active
🇹🇼 Taiwan
Scar-D
Reg #: 3009317711
·
FEI: 3009317711
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CORELEADER BIOTECH CO., LTD
- Registration Number
- 3009317711
- FEI Number
- 3009317711
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 19F, No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist.
- City
- New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K111733
Owner / Operator
- Firm Name
- Coreleader Biotech Co., Ltd
- Operator Number
- 10040141
- Address
- 19F, No. 100, Sec. 1, Xintai 5th Rd., Xizhi Dist.
- City
- New Taipei
- State
- TW-NWT
- Postal Code
- 22102
- Country
- TW
- Correspondent
- Teeming Tsao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2012-03-13 |
Proprietary Names
Scar-D
Establishment Types
Manufacture Medical Device