Data / Medical devices / China / Foshan United Medical Technologies Ltd.
Foshan United Medical Technologies Ltd.: FDA-registered device maker in Foshan Guangdong, China, 3 510(k) clearances
Foshan United Medical Technologies Ltd. is registered with the FDA (registration 3009109670) in Foshan Guangdong, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 24, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009109670
- Address
- No. 1 Huixing Road, Yanbu, Dali, Nanhai, Foshan, Guangdong Province,528247, China, Foshan Guangdong, China, 528247
- Owner or operator
- Foshan United Medical Technologies Ltd. (10091252)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 1, 2024
- Registered through
- 2026
- Brand names listed
- AlgCel Ag; Silver Alginate Wound Dressing, AlgCel; Alginate wound dressing, CelloCel; CMC wound dressing, Kytocel; Chitosan dressing, PU Film Dressing, Polyurethane film dressings, SequaSan; Chitosan wound dressing, Wound Closure Device;SEQUAhold
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closure, Wound, Adhesive | MGO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | 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 24, 2024 | K233111 | ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC | FRO | Substantially Equivalent | Foshan United Medical Technologies, Ltd. | accessdata.fda.gov |
| May 11, 2018 | K172570 | ALGS6 Ag Alginate Wound Dressing | FRO | Substantially Equivalent | Foshan United Medical Technologies, Ltd. | accessdata.fda.gov |
| January 26, 2015 | K143124 | KA01 Chitosan Wound Dressing | KGN | Substantially Equivalent | Foshan United Medical Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrophilic
- All makers of Dressing, Wound, Occlusive
- All makers of Closure, Wound, Adhesive
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated May 24, 2024. 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.