Bioland Technology Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 3 device types, 13 products catalogued, 8 clearances.
Bioland Technology Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Continuous Measurement Thermometer, System, Test, Blood Glucose, Over The Counter and 1 other device type. 13 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | BIOLAND TECHNOLOGY LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004101980 |
| FEI number | 3004101980 |
| DUNS | 545852548 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 爱奥乐医疗器械（深圳）有限公司 |
|---|---|
| Unified social credit code | 91440300754279378E |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | A6B7 (BLOCK G), SHANGRONG IND. ZONE, BAOLONG 5th RD, |
| Postal code | 518116 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | Digital Thermometer, T104 Digital Themrmometer, T103 Digital Themrmometer, Infrared Thermometer, E127, Infrared Thermometer (Model:E201) | 2020 | 115 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 2005, 2006-2B, 2006, 2006-2, 2005-1, ABP-2005-1 and 2 more | 2020 | 98 |
| System, Test, Blood Glucose, Over The Counter | Class 2 | Bioland G-425-2V Blood Glucose Monitoring System, Glucoracy G-425-2 blood glucose monitoring system, Caring mill G-425-2 blood glucose monitoring system, Bioland G-425-2 Blood Glucose Monitoring System, LK-M2V Blood Glucose Monitoring System(Model:G-425-2V), YONLO Blood Glucose Monitoring System(Model: G-425-2V) and 8 more | 2020 | 20 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K202739 | 2022-08-12 | NBW | Special | This company |
| K213011 | 2022-04-05 | FLL | Traditional | This company |
| K201879 | 2021-03-31 | FLL | Traditional | This company |
| K202934 | 2021-01-26 | DXN | Traditional | This company |
| K201161 | 2020-10-02 | FLL | Traditional | This company |
| K201467 | 2020-09-21 | DXN | Traditional | This company |
| K191657 | 2020-03-20 | NBW | Traditional | This company |
| K083681 | 2009-01-16 | DXN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Main products | blood glucose meters, blood pressure monitors, uric acid analyzers, multi-parameter detectors |
| Certifications | FDA, CE, MDSAP, ISO, NMPA |
| Export markets | more than 75 countries worldwide |
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.