Data / Medical devices / China / Shenzhen Kesite Digital Technology Co., Ltd.
Shenzhen Kesite Digital Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 6 510(k) clearances
Shenzhen Kesite Digital Technology Co., Ltd. is registered with the FDA (registration 3039443708) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039443708
- Address
- 1508E2, Building A, Xingheshiji, No. 3069, Caitian Road, Gangxia Community, Futian Street, Futian District, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Kesite Digital Technology Co., Ltd. (10093764)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 4, 2025
- Registered through
- 2026
- Brand names listed
- Aipyce Female External Catheter, Breaspec Skin Tag Remover Kit, Female External Catheter, GJW Wart and Skin Tag Remover, Model Number: GJW-02, GJW-03, HM-CRYO Tag & Wart Removal Kit, Itkemod Male External Catheter, L.C.S.3000 Skin Removal Kit, PoZent Tongue Stabilizing Device Mouthpiece; IFGZQU Tongue Stabilizing Device Mouthpiece and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | 1 | Manufacturer | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | 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 22, 2025 | K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | GEH | Substantially Equivalent | Cryoconcepts LP | accessdata.fda.gov |
| January 21, 2025 | K242288 | Advanced Cryo Wart Remover | GEH | Substantially Equivalent | Medical Brands Laboratories B.V. | accessdata.fda.gov |
| September 18, 2023 | K231663 | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | LRK | Substantially Equivalent | Innovative Health Technologies (Nz), Ltd. | accessdata.fda.gov |
| July 1, 2021 | K210910 | Snore Bandit | LRK | Substantially Equivalent | Snorebandit, LLC | accessdata.fda.gov |
| June 27, 1994 | K940140 | HM-CRYO | GEH | Substantially Equivalent | Hill-Med, Inc. | accessdata.fda.gov |
| October 31, 1980 | K801921 | GCS-79 | GEH | Substantially Equivalent | Gilmore Liquid Air Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Cryosurgical, Accessories
- All makers of Collector, Urine, Powered, Non Indwelling Catheter
- All makers of Device, Anti-Snoring
- All makers of Lamp, Infrared, Therapeutic Heating
Updated May 22, 2025. 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.