Data / Medical devices / China / Shenzhen Combei Technology Co.,ltd.
Shenzhen Combei Technology Co.,ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Shenzhen Combei Technology Co.,ltd. is registered with the FDA (registration 3013561145) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 29, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013561145
- Address
- No.105, Huanguan South Road, Dahe Community, Guanhu Street, Longhua District, Shenzhen Guangdong, China, 518110
- Owner or operator
- SHENZHEN COMBEI TECHNOLOGY CO.,LTD (10054917)
- Roles
- Manufacturer
- First device listed
- May 12, 2017
- Registered through
- 2027
- Brand names listed
- Arm Type Blood Pressure Monitor, model: BP105A, BP103A, BP102A, BP101A, BP100A, Arm Type Blood Pressure Monitor, model: BP136A, BP126A, BP122A, BP118A, BP116A, BP108A, BP106A, Arm Type Blood Pressure Monitor, model: BP810A, BP800A, BP660A, BP200A, BP168A, BP163A, BP156A-A, BP156A, Arm Type Blood Pressure Monitor, model: BPT801, BPCB0A-3H, BPCB0A-3A, BPCB0A-2H, BPCB0A-2A, BP880A, BP866A, BP820A, CHOICEMMED, Blood pressure monitor, model: CBP1K1, CHOICEMMED, Blood pressure monitor, model: CBP1K2, CHOICEMMED, Blood pressure monitor, model: CBP1K3, CHOICEMMED, Blood pressure monitor, model: CBP2K1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 29, 2018 | K181104 | Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style | DXN | Substantially Equivalent | Shenzhen Combei Technology Co., Ltd. | accessdata.fda.gov |
| January 10, 2018 | K171833 | Digital Blood Pressure Monitor-Wrist Style | DXN | Substantially Equivalent | Shenzhen Combei Technology Co., Ltd. | accessdata.fda.gov |
| May 9, 2017 | K163606 | Digital Blood Pressure Monitor-Automatic Upper Arm Style | DXN | Substantially Equivalent | Shenzhen Combei Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Clinical Electronic Thermometer
- All makers of Pad, Heating, Powered
Updated August 29, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.