Data / Medical devices / China / Bioland Technology Ltd.
Bioland Technology Ltd.: FDA-registered device maker in SHENZHEN Guangdong, China, 7 510(k) clearances
Bioland Technology Ltd. is registered with the FDA (registration 3004101980) in SHENZHEN Guangdong, China. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 12, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004101980
- Address
- A6B7 And A5B6, Shangrong Industrial Zone No.2, Baolong Fifth Road,Baolong Community, Baolong Street, Longgang District, SHENZHEN Guangdong, China, 518116
- Owner or operator
- BIOLAND TECHNOLOGY LTD. (9057599)
- Roles
- Manufacturer
- First device listed
- October 16, 2020
- Registered through
- 2027
- Brand names listed
- 2005, 2005-1, 2006, 2006-2, 2006-2B, 2008 Blood Pressure Monitor, A221-2 Blood Pressure Monitor, ABP-2005-1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 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 12, 2022 | K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
| April 5, 2022 | K213011 | Infrared Thermometer (model: E201) | FLL | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
| March 31, 2021 | K201879 | Digital Thermometer Model T103, T104 | FLL | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
| January 26, 2021 | K202934 | Blood Pressure Monitor | DXN | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
| October 2, 2020 | K201161 | Infrared Thermometer Model E127 | FLL | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
| September 21, 2020 | K201467 | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | DXN | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
| March 20, 2020 | K191657 | Bioland Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated August 12, 2022. 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.