FDA Registration
Active
🇹🇼 Taiwan
Needle, fistula
Reg #: 9616419
·
FEI: 3003656001
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SUNDER BIOMEDICAL TECH. CO., LTD.
- Registration Number
- 9616419
- FEI Number
- 3003656001
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 16, Chung-Chen Rd., Chung-Ming Village, Pao-Chung Hsiang,
- City
- Yunlin County
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K003123
Owner / Operator
- Firm Name
- SUNDER BIOMEDICAL TECH. CO., LTD.
- Operator Number
- 9040038
- Address
- No. 16, Chung-Chen Rd., Chung-Ming Village, Pao-Chung Hsiang,
- City
- Yunlin County
- State
- TW-NOTA
- Postal Code
- 634
- Country
- TW
- Correspondent
- Kevin - Hu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Fistula | FIE | Class 2 | Gastroenterology, Urology | No | 2016-11-21 |
Proprietary Names
Needle, fistula
Establishment Types
Manufacture Medical Device