Data / Medical devices / Taiwan / Benq Materials Corporation
Benq Materials Corporation: FDA-registered device maker in Gueishan Taoyuan, Taiwan, 1 510(k) clearance
Benq Materials Corporation is registered with the FDA (registration 3010256218) in Gueishan Taoyuan, Taiwan. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 4, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010256218
- Address
- 29, Jianguo E. Rd., Gueishan Taoyuan, Taiwan, 333403
- Owner or operator
- BENQ MATERIALS CORPORATION (10044989)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 9, 2013
- Registered through
- 2026
- Brand names listed
- AnsCare Hydrocolloid Dressing (Sterile), AnsCare LeniScar Silicone Stick, AnsCare Scar Reduction Silicone Gel C+, Anscare SIMO Negative Pressure Wound Therapy (NPWT) System, StatGuard Hemostatic Dressing, StatGuard Hemostatic Patch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Contract manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Non-Powered Suction Apparatus | OKO | 2 | Manufacturer | accessdata.fda.gov |
| Nursing Pad, Hydrogel | NTC | 1 | 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 |
|---|---|---|---|---|---|---|
| May 4, 2020 | K193185 | Anscare SIMO Negative Pressure Wound Therapy (NPWT) System | OKO | Substantially Equivalent | Benq Materials Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Negative Pressure Wound Therapy Non-Powered Suction Apparatus
- All makers of Dressing, Wound, Hydrophilic
- All makers of Nursing Pad, Hydrogel
- All makers of Elastomer, Silicone, For Scar Management
Updated May 4, 2020. 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.