Data / Medical devices / Taiwan / Cenefom Corp
Cenefom Corp: FDA-registered device maker in Zhunan Township Miaoli, Taiwan, 1 510(k) clearance
Cenefom Corp is registered with the FDA (registration 3010610457) in Zhunan Township Miaoli, Taiwan. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 15, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010610457
- Address
- 3F, No. 50-3, Keyan Rd., Zhunan Township Miaoli, Taiwan, 35053
- Owner or operator
- Cenefom Corp. (10045592)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- December 5, 2013
- Registered through
- 2026
- Brand names listed
- CENEFOM, Cenefom, Disposable Sampling Swab, Disposable Sterile Sampling Swab, Ophthalmic sponges, pva sponge, internal, x-ray detectable
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Exporter to the US | accessdata.fda.gov |
| Balloon, Epistaxis | EMX | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Contract manufacturer | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 15, 2008 | K082460 | CENEFOM PVA SURGICAL SPEAR | HOZ | Substantially Equivalent | Longtek Scientific Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Sponge, Ophthalmic
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Splint, Intranasal Septal
- All makers of Balloon, Epistaxis
Updated December 15, 2008. 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.