Data / Medical devices / Taiwan / Sunder Biomedical Tech. Co., Ltd.
Sunder Biomedical Tech. Co., Ltd.: FDA-registered device maker in Yunlin County, Taiwan, 2 510(k) clearances
Sunder Biomedical Tech. Co., Ltd. is registered with the FDA (registration 9616419) in Yunlin County, Taiwan. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 18, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616419
- FEI number
- 3003656001
- Address
- No. 16, Chung-Chen Rd., Chung-Ming Village, Pao-Chung Hsiang, Yunlin County, Taiwan, 63441
- Owner or operator
- SUNDER BIOMEDICAL TECH. CO., LTD. (9040038)
- Roles
- Manufacturer
- First device listed
- August 29, 2007
- Registered through
- 2026
- Brand names listed
- Needle, fistula, SUNDER Connection Suction/Drainage Bag, SUNDER SUCTION BAG, SUNDER Tracheal Stoma Retainer and Accessory, SUNDER nasal oxygen cannula, Set, tubing, blood, with and without anti-regurgitation valve, TRANSDUCER, GAS PRESSURE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Fistula | FIE | 2 | Manufacturer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Manufacturer | accessdata.fda.gov |
| Tonsillectome | KCA | 1 | Manufacturer | accessdata.fda.gov |
| Transducer, Gas Pressure | BXO | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 18, 2002 | K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET | FJK | Substantially Equivalent | Sunder Biomedical Tech. Co., Ltd. | accessdata.fda.gov |
| May 4, 2001 | K003123 | RENAX A.V. FISTULA NEEDLE SETS | FIE | Substantially Equivalent | Sunder Biomedical Tech. Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bottle, Collection, Vacuum
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- All makers of Tonsillectome
- All makers of Tube, Aspirating, Flexible, Connecting
- All makers of Needle, Fistula
- All makers of Transducer, Gas Pressure
Updated November 18, 2002. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.