Xuzhou Kernel Medical Equipment Co Ltd
Xuzhou Jiangsu, CN
XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD appears in FDA device records in Xuzhou Jiangsu, CN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Xuzhou Kernel Medical Equipment Co Ltd between 2014 and 2026. The busiest year on record is 2019, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2016 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) | Substantially Equivalent | ||
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | FTC | Substantially Equivalent | |
| K222751 | LED Light Therapy Device, KN-7000L | GEX | Substantially Equivalent | |
| K200971 | 308nm Excimer System | FTC | Substantially Equivalent | |
| K200929 | Hair Growth System | OAP | Substantially Equivalent | |
| K190685 | Hair Growth System | OAP | Substantially Equivalent | |
| K181805 | UV Phototherapy | FTC | Substantially Equivalent | |
| K160341 | Colposcope System | HEX | Substantially Equivalent | |
| K132643 | UV PHOTOTHERAPY | FTC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008393409 | 3008393409 | XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD | Kernel Mansion, Xuzhou Jiangsu 221004 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain