Data / Medical devices / China / Macmed Technology Inc.
Macmed Technology Inc.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Macmed Technology Inc. is registered with the FDA (registration 3031887985) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 12, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031887985
- Address
- Room#706, Building 40, Xialang Industrial Zone, Heshui Kou Community, Matian Subdistrict, Guangming District, Shenzhen Guangdong, China, 518106
- Owner or operator
- Macmed Technology Inc. (10091369)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 2, 2024
- Registered through
- 2026
- Brand names listed
- C0 2 sensor, Macmed ECG electrodes, Water trap and set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Exporter to the US | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Drain, Tee (Water Trap) | BYH | 1 | Exporter to the US | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Exporter to the US | accessdata.fda.gov |
| System, Pressure Measurement, Intermittent | JFC | 1 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Pneumatic | KCY | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| January 12, 2006 | K053174 | LOFLO C5 CO2 SENSOR | CCK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Drain, Tee (Water Trap)
- All makers of Tourniquet, Pneumatic
- All makers of Electrode, Electrocardiograph
- All makers of System, Pressure Measurement, Intermittent
- All makers of Cable, Electrode
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Updated January 12, 2006. 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.