Shenzhen Medke Technology Co., Ltd.
Shenzhen Guangdong, CN
SHENZHEN MEDKE TECHNOLOGY CO., LTD. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 3 510(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 3 510(k) clearances for Shenzhen Medke Technology Co., Ltd. between 2016 and 2025. The busiest year on record is 2016, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | FLL | Substantially Equivalent | |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | DXQ | Substantially Equivalent | |
| K152390 | Medke Oximetry Finger Sensor | DQA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012804266 | 3012804266 | SHENZHEN MEDKE TECHNOLOGY CO., LTD. | 401, 503, Bldg. A1, Anle Ind. Zone, No.172, Hangcheng RD, Sanwei Community, Hangcheng Street, Baoan District, Shenzhen Guangdong 518126 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