Munktell Filter AB
Country not established
- Devices
- 2
What Munktell Filter AB makes
Munktell Filter AB manufactures high-efficiency particulate air (HEPA) filters and respiratory filters, including the BACSTOP FILTER and GARD FILTER series, designed for medical and healthcare applications. These products are engineered to remove bacteria and airborne contaminants, such as those in humidifying systems (HME) and breathing circuits. The BACSTOP FILTER/HME and COMBIGARD FILTER/HME variants are specifically tailored for use in respiratory therapy and patient ventilation systems.
The company’s portfolio is classified under FDA’s Class II medical devices and is subject to 510(k) clearance requirements in the United States. These devices are listed in the FDA’s 510(k) database, adhering to regulatory standards for performance, safety, and efficacy in their intended medical applications. The manufacturer operates from the United States, aligning its products with U.S. regulatory frameworks.
Catalogue
Bacstop Filter, Bacstop Filter/Hme Ref K014282
Regimes: 510(k) Registry: 510(k)Gard Filter, Combigard Filte / Hme Ref K014281
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Munktell Filter AB have in the registry?
The registry currently lists 2 devices for Munktell Filter AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Munktell Filter AB's devices?
Among its 2 most recently registered devices, Munktell Filter AB has devices listed in FDA 510(k) (2 devices).
What risk classes do Munktell Filter AB's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Munktell Filter AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Munktell Filter AB in the registry?
The most recently registered devices listed for Munktell Filter AB include BACSTOP FILTER, BACSTOP FILTER/HME and GARD FILTER, COMBIGARD FILTE / HME.