Shenzhen Combei Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 3 device types, 4 products catalogued, 4 clearances.
Shenzhen Combei Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Pad, Heating, Powered, Clinical Electronic Thermometer and 1 other device type. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
Registration
| Registered name | SHENZHEN COMBEI TECHNOLOGY CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013561145 |
| FEI number | 3013561145 |
| DUNS | 529383632 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市康贝科技有限公司 |
|---|---|
| Unified social credit code | 914403006658546094 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | No.105, Huanguan South Road, Dahe Community, Guanhu Street, Longhua District |
| Postal code | 518110 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | Infrared Forehead Thermometer, Model: FR200, NC8, NC200, NC100, NC600, NC300, Infrared ear thermometer, Model: IR100, IR200, Dual mode Infrared thermometer, Model: IFM100 | 2025 | 49 |
| Pad, Heating, Powered | Class 2 | Insect Bite Relief, IBH-001, Insect Bite Healer, Model IH-W03 | 2022 | 144 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Wrist Style, Blood pressure monitor, model: BP810W BP602W BP608W BP606W BP660W BP830W BP866W, CHOICEMMED, Blood pressure monitor, model: CBP2K2, CHOICEMMED, Blood pressure monitor, model: CBP2K1, Dynarex, Blood pressure monitor, model: 7095, Wrist Style, Blood pressure monitor, model: BP800W BP603W BP880W BP885W BPCBOA-2F BP850W BP300W, HOMIEE, Blood pressure monitor, model: BP2001 and 19 more | 2017 | 98 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Homiee | DXN | 5 |
| Medisana, Blood pressure monitor | DXN | 2 |
| Hylogy | DXN | 1 |
| Ybwm | DXN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K202741 | 2021-07-07 | FLL | Traditional | This company |
| K181104 | 2018-08-29 | DXN | Traditional | This company |
| K171833 | 2018-01-10 | DXN | Traditional | This company |
| K163606 | 2017-05-09 | DXN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Employees | 73 |
| Main products | Electric blood pressure monitors, Infrared thermometers, Medical ultrasonic nebulizers |
| Certifications | ISO9001 |
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.