Shenzhen Kesite Digital Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 4 device types.
Shenzhen Kesite Digital Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Device, Anti-Snoring, Unit, Cryosurgical, Accessories and 2 other device types. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | SHENZHEN KESITE DIGITAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3039443708 |
| FEI number | 3039443708 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 1508E2, Building A, Xingheshiji, No. 3069, Caitian Road, Gangxia Community, Futian Street, Futian District |
| Postal code | 518000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Collector, Urine, Powered, Non Indwelling Catheter | Class 1 | Itkemod Male External Catheter, Aipyce Female External Catheter, Female External Catheter | 2026 | 13 |
| Device, Anti-Snoring | Class 2 | Upverxi Snore Mouthguard; SnoreBandit Anti-Snoring Appliance, PoZent Tongue Stabilizing Device Mouthpiece; IFGZQU Tongue Stabilizing Device Mouthpiece | 2025 | 8 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Red Light Therapy Device | 2025 | 235 |
| Unit, Cryosurgical, Accessories | Class 2 | HM-CRYO Tag & Wart Removal Kit, Breaspec Skin Tag Remover Kit, GJW Wart and Skin Tag Remover, Model Number: GJW-02, GJW-03, L.C.S.3000 Skin Removal Kit, Wart and Skin Tag Remover | 2025 | 3 |
Clearances
No clearance names Shenzhen Kesite Digital Technology Co., Ltd. as applicant. 6 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251493 | 2025-05-22 | GEH | Special | Cryoconcepts LP |
| K242288 | 2025-01-21 | GEH | Traditional | Medical Brands Laboratories B.V. |
| K231663 | 2023-09-18 | LRK | Traditional | Innovative Health Technologies (NZ) Limited |
| K210910 | 2021-07-01 | LRK | Traditional | Snorebandit, LLC |
| K940140 | 1994-06-27 | GEH | Traditional | Hill-Med, Inc. |
| K801921 | 1980-10-31 | GEH | Traditional | Gilmore Liquid Air Co. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Cryotherapy solutions for warts, Anti-snoring devices, Fetal Doppler devices |
|---|
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.