Data / Medical devices / United States / Metene Limited
Metene Limited: FDA-registered device maker in City of Industry, CA, United States, 11 510(k) clearances
Metene Limited is registered with the FDA (registration 3015967131) in City of Industry, CA, United States. It lists 7 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015967131
- Address
- 17800 Castleton ST Ste 665, City of Industry, CA, United States, 91748
- Owner or operator
- METENE LIMITED (10061462)
- Roles
- Specification developer
- First device listed
- May 10, 2020
- Registered through
- 2026
- Brand names listed
- D6606US Electronic blood pressure monitor, ELECTRIC HOSPITAL BED, HTD8813C THERMOMETER, LPOW A310E pulse oximeter, MECHANICAL WHEELCHAIR, Metene Blood Pressure Monitor, Model:TMB-1117-SN, Metene Enhance Blood Glucose Monitoring System, metene B15 Blood Pressure Monitor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 | Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Specification developer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Specification developer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 20, 2023 | K233130 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| December 5, 2023 | K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | DXN | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| June 25, 2020 | K200437 | Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Jamr Technology Co., Ltd. | accessdata.fda.gov |
| September 13, 2019 | K190869 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Aeon Technology Co., Ltd. | accessdata.fda.gov |
| May 8, 2019 | K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | NBW | Substantially Equivalent | Hmd Biomedical, Inc. | accessdata.fda.gov |
| July 23, 2018 | K171888 | Non-contact infrared body thermometer | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| October 13, 2017 | K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | NBW | Substantially Equivalent | All Medicus Co., Ltd. | accessdata.fda.gov |
| September 29, 2015 | K151100 | U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| October 22, 2012 | K122482 | TRANSTEK WRIST BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| July 6, 2006 | K061181 | ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207 | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
| July 20, 2004 | K041814 | FS SERIES WHEELCHAIR | IOR | Substantially Equivalent | Foshan Dongfang Medical Equipment Manufactory(Ltd) | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Bed, Ac-Powered Adjustable Hospital
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Oxidase, Glucose
- All makers of Oximeter
- All makers of Wheelchair, Mechanical
Updated December 20, 2023. 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.