METENE LIMITED

FDA Device Registration & Listing · City of Industry, CA, US · Registration 3015967131

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
3015967131
FEI Number
3015967131
Entity Name
METENE LIMITED
City/State/Country
City of Industry, CA, US
Establishment Address
17800 CASTLETON ST STE 665, City of Industry, CA 91748, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
METENE LIMITED (Owner Number: 10061462)
Owner / Operator Contact Address
17800 CASTLETON ST STE 665, City of Industry, CA 91748, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K122482
PMA Number
N/A

All Registered Proprietary Names

metene S Blood Glucose Monitoring System MECHANICAL WHEELCHAIR metene TD-4116 blood glucose monitoring system Metene Enhance Blood Glucose Monitoring System ELECTRIC HOSPITAL BED metene Wrist Blood Pressure Monitor,Model:TMB-1581-ZY HTD8813C THERMOMETER metene B15 Blood Pressure Monitor Metene Blood Pressure Monitor, Model:TMB-1117-SN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2025-05-18
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2025-05-18
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2024-12-26
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2024-11-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2024-11-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-06-29
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2025-05-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-11-19
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-11-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-11-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-11-19

Official Correspondent

YANYANG CHE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

METENE LIMITED
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
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K811074 Reagents Applications, Inc. GLUCOSE REAGENT-ENZYMATIC-COLOR 500 1981-04-29
K936212 Heraeus Kulzer, Inc. GLUCOFILM TEST STRIPS 1994-05-10
K935211 Brookefield Hunter, Inc. WALK N CHAIR 1994-02-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0043-06 Abbott Laboratories Medisense Products 2
Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06 Instrumentation Laboratory Co. 2
GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015967131. Last updated year: 2026. Please use registration number 3015967131 when referencing this establishment in official correspondence.
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