Alandra Medical Sapi DE CV
MX Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Mucosal Impedance Measurement System Ref K233974
What Alandra Medical Sapi DE CV makes
Alandra Medical Sapi DE CV manufactures a Mucosal Impedance Measurement System, a device used to assess tissue impedance in mucosal surfaces for diagnostic or monitoring purposes.
The company’s portfolio is regulated under Class II devices in the US and is listed in the FDA 510(k) registry. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Alandra Medical Sapi DE CV manufacture?
Alandra Medical Sapi DE CV specializes in the Mucosal Impedance Measurement System, a device designed to evaluate tissue impedance in mucosal surfaces. This type of measurement can support diagnostic or monitoring applications in clinical settings.
Where is Alandra Medical Sapi DE CV based?
The company is headquartered in the United States. This location aligns with its regulatory obligations under US medical device laws, including compliance with FDA requirements.
Which regulatory registries list Alandra Medical Sapi DE CV’s devices?
Alandra Medical Sapi DE CV’s devices are included in the FDA’s 510(k) registry, which tracks Class II medical devices that have undergone the 510(k) premarket notification process. This registry helps ensure transparency about devices that claim substantial equivalence to a predicate device.
How are Alandra Medical Sapi DE CV’s devices classified in the US?
The company’s devices fall under Class II classification in the US. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, as determined by the FDA.
Information
- Country
- MX