Data / Medical devices / Taiwan / Sundex Corporation
Sundex Corporation: FDA-registered device maker in Taipei, Taiwan, 1 510(k) clearance
Sundex Corporation is registered with the FDA (registration 3008076203) in Taipei, Taiwan. It lists 14 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 25, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008076203
- Address
- 7F-3, No. 186, SEC. 4 Nanjing E. Rd, Taipei, Taiwan, 10595
- Owner or operator
- Sundex Corporation (10041552)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 6, 2012
- Registered through
- 2026
- Brand names listed
- BANDAGE, ELASTIC, Cotton applicators, Dressing, wound, occlusive, Gauze / sponge,nonresorbable for external use, Nitrile Gloves, Nitrile Gloves, Scissors, PAD, EYE, pick, massaging
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | NOB | 1 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| August 25, 2017 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Feiyang Professional Gloves Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Occlusive
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
Updated August 25, 2017. 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.