Data / Medical devices / Taiwan / TAIWAN BIOMATERIAL Company, Ltd.
TAIWAN BIOMATERIAL Company, Ltd.: FDA-registered device maker in Zhubei Hsinchu(County), Taiwan, 1 510(k) clearance
TAIWAN BIOMATERIAL Company, Ltd. is registered with the FDA (registration 3014590707) in Zhubei Hsinchu(County), Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 21, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014590707
- Address
- 1F, No. 188, Sec. 1, Shengyi Rd., Zhubei City, Hsinchu County, Zhubei Hsinchu(County), Taiwan, 302058
- Owner or operator
- Taiwan Biomaterial Co., Ltd. (10058651)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- February 22, 2019
- Registered through
- 2026
- Brand names listed
- Imperative Care Pump, TRUVIC Generator, TRUVIC Peripheral Canister, TRUVIC Tubeset, Vascular Canister, Vascular Tubeset, ZOOM Aspiration Tubing, Zoom Aspiration Tubing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Thrombus Retriever | NRY | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| February 21, 2019 | K190105 | ZOOM Aspiration Pump | JCX | Substantially Equivalent | Taiwan Biomaterial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Ward Use, Portable, Ac-Powered
- All makers of Catheter, Thrombus Retriever
Updated February 21, 2019. 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.