FDA Registration
Active
🇹🇼 Taiwan
SUNDER BIOMEDICAL TECH. CO., LTD.
Reg #: 9616419
·
FEI: 3003656001
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SUNDER BIOMEDICAL TECH. CO., LTD.
- Registration Number
- 9616419
- FEI Number
- 3003656001
- Status
- Active
- Expiry Year
- 2026
- 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
- K014140
Owner / Operator
- Firm Name
- SUNDER BIOMEDICAL TECH. CO., LTD.
- Operator Number
- 9040038
- Address
- No. 16, Chung-Chen Rd., Chung-Ming Village
- City
- Pao-Chung Hsiang
- State
- Yunlin
- Postal Code
- 63441
- Country
- TW
- Correspondent
- Kevin - Hu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2025-09-25 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2007-08-29 |
| Needle, Fistula | FIE | Class 2 | Gastroenterology, Urology | No | 2016-11-21 |
| Transducer, Gas Pressure | BXO | Class 1 | Anesthesiology | No | 2010-09-10 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2025-09-25 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2025-04-07 |
| Tonsillectome | KCA | Class 1 | Ear, Nose, Throat | No | 2025-09-26 |
Proprietary Names
SUNDER SUCTION BAG
Set, tubing, blood, with and without anti-regurgitation valve
Needle, fistula
TRANSDUCER, GAS PRESSURE
SUNDER nasal oxygen cannula
SUNDER Connection Suction/Drainage Bag
SUNDER Tracheal Stoma Retainer and Accessory
Establishment Types
Manufacture Medical Device