BIOLAND TECHNOLOGY LTD.

FDA Device Registration & Listing · SHENZHEN Guangdong, CN · Registration 3004101980

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004101980
FEI Number
3004101980
Entity Name
BIOLAND TECHNOLOGY LTD.
City/State/Country
SHENZHEN Guangdong, CN
Establishment Address
A6B7 (BLOCK G), SHANGRONG IND. ZONE, BAOLONG 5th RD,, LONGGANG DISTRICT,, SHENZHEN Guangdong 518116, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BIOLAND TECHNOLOGY LTD. (Owner Number: 9057599)
Owner / Operator Contact Address
A6B7 (Block G), SHANGRONG IND. ZONE, BAOLONG 5TH RD., LONGGANG DISTRICT, SHENZHEN, CN-GD 518116, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201879
PMA Number
N/A

All Registered Proprietary Names

Infrared Thermometer (Model:E201) Blood Pressure Monitor 2006-2B 2005-1 2006-2 2006 2005 ABP-2005-1 Blood Pressure Monitor A221-2 Blood Pressure Monitor 2008 Blood Pressure Monitor A220 Bioland blood glucose monitoring system(Model:G-427B) Fipeo G-427B blood glucose monitoring system Andesfit ADF-B27 blood glucose monitoring system(Model:G-427B) Elera G-427B blood glucose monitoring system MG1 Blood Glucose Monitoring System(Model:G-427B) G-425-3 Blood Glucose Monitoring System Oxiline Gluco X Pro Blood Glucose Monitoring System(Model:G-427B) Fond Circle FBG-M1 Blood Glucose Monitoring System(Model:G-427B) GT-600 Blood Glucose Monitoring System Bioland G-425-2V Blood Glucose Monitoring System LK-M2V Blood Glucose Monitoring System(Model:G-425-2V) Glucoracy G-425-2 blood glucose monitoring system Bioland G-425-2 Blood Glucose Monitoring System Caring mill G-425-2 blood glucose monitoring system G-425-1 G-666B Blood Glucose Monitoring System Infrared Thermometer E127 E126 Digital Thermometer T104 Digital Themrmometer T103 Digital Themrmometer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-04-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-10-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-02-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-11-01
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2022-08-22
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-10-16
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

BIOLAND TECHNOLOGY LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0004-2009 Lifescan Inc 2
One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06 Abbott Laboratories Medisense Products 2
FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

Similar Registrations

Registration Number Establishment Name Location
1062836 DIGICARE BIOMEDICAL TECHNOLOGY, INC. BOYNTON BEACH, FL, US
3009487317 SHENZHEN JUZHONG TECHNOLOGY CO.,LTD shenzhen Guangdong, CN
9681837 ME CENTER OF TERUMO CORP. FUJINOMIYA Shizuoka, JP
3038761440 Corsano Health SA Plan-les-Ouates Geneve, CH
3016595211 DYNAMIC EMS LTD Dalgety Bay Fife, GB
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004101980. Last updated year: 2026. Please use registration number 3004101980 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.