Xinkang Medical Instrument Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 2 device types, 2 clearances.
Xinkang Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Cable, Transducer And Electrode, Patient, (Including Connector). Its earliest product listing with the FDA dates from 2020.
2device types registered with the FDA
2510(k) clearances
Registration
| Registered name | XINKANG MEDICAL INSTRUMENT CO. LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017953522 |
| FEI number | 3017953522 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市鑫康医疗器械有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 808, Building 6, Hengda Fashion Valley Building (East District), Fulong Road, Shanghenglang Community |
| Postal code | 518100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | ECG Cables and Leadwires, Model: G2202B10A, G2202C10A, G2202S10A, E2101C5A, E2101C3A, E2101S3A, E2101S5A | 2020 | 22 |
| Oximeter | Class 2 | Xinkang, BCI 9Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS1, Xinkang, NELLCOR 14Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF2, Xinakng, Nellcor 9pin Oximax Disposable Adult L type Non-woven Spo2 Sensor, model: XDBN, Xinkang, Mindray T5 7Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS4, Xinkang, Mindray 6Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF3, Xinkang, GE2500 11Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAE4 and 30 more | 2020 | 70 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K201359 | 2020-10-01 | DSA | Traditional | This company |
| K201360 | 2020-08-19 | DQA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Employees | 51-100 |
| Main products | SpO2 sensor, ECG trunk cable, NIBP cuff, temperature probe |
| Certifications | CE, FDA, ISO13485 |
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.
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