Shenzhen Caremed Medical Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 8 device types, 4 products catalogued, 6 clearances.
Shenzhen Caremed Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Cable, Electrode and 6 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | Shenzhen Caremed Medical Technology Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011713222 |
| FEI number | 3011713222 |
| DUNS | 544335718 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市凯曼医疗技术有限公司 |
|---|---|
| Unified social credit code | 914403000775087421 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 3/F, Building C, Xiazao Digital Industrial Park, No. 8 Huali Road |
| Postal code | 518109 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face mask | 2020 | 439 |
| Binder, Abdominal | Class 1 | Caremed Diaposable Abdominal belt, Caremed resuable Abdominal belt | 2015 | 20 |
| Blood Pressure Cuff | Class 2 | N1C-TS, N1N-PS, N1AL-TS, N1S-TD, N1N5-TD, N1I-PD and 33 more | 2019 | 50 |
| Cable, Electrode | Class 2 | Disposable ECG cable, KM-82080 | 2018 | 47 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | Caremed Patient Cable and Leadwires for ECG,EKG,SpO2 and Blood Pressure Monitors, EK10R-SH1-PA, ED5R-90S-A, KM-82096, KM-PA01048B, KM-82060/E and 17 more | 2016 | 22 |
| Continuous Measurement Thermometer | Class 2 | TRAG-2252, TRCG-2252, Temperature probe, TRAS-2252, TRCS-2252, Caremed Reusable Temperature Probe and 1 more | 2015 | 115 |
| Mask, Scavenging | Class 1 | Dispoable face mask | 2020 | 158 |
| Oximeter | Class 2 | C503-16, C543-16, C533-16, C523-16, C503-01, C503-49 and 47 more | 2017 | 70 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K191279 | 2019-12-06 | DQA | Traditional | This company |
| K182751 | 2019-09-06 | FLL | Traditional | This company |
| K182755 | 2018-12-21 | FLL | Traditional | This company |
| K182433 | 2018-12-17 | DXQ | Traditional | This company |
| K153184 | 2017-01-04 | DQA | Traditional | This company |
| K153188 | 2016-10-24 | DSA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Factory area | 11000 m² |
| Main products | SpO2 sensors, ECG cables and leadwires, Temperature probes, NIBP cuffs, Monitoring equipment accessories |
| Certifications | NMPA (China), ISO 13485, FDA, CE |
| Export markets | 128 countries and regions |
| OEM and ODM | Offered |
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.