Althin Medical AB
SwedenFDA applicant, unverified
- Devices
- 7
What Althin Medical AB makes
Althin Medical AB manufactures hemodialyzers, including models such as the AF-220, A-15, and AF-150, as well as the Althin Medical AB Altracart II. These devices are designed for renal dialysis procedures, facilitating the removal of waste and excess fluids from a patient’s blood during treatment.
The company’s hemodialyzers are classified as Class II medical devices in the US and are listed under the FDA’s 510(k) pathway. The portfolio is regulated under US jurisdiction, with no additional international registries specified.
Catalogue
Af-220 Hemodialyzer Ref K992573
Regimes: 510(k) Registry: 510(k)A-15 Hemodialyzer Ref K992594
Regimes: 510(k) Registry: 510(k)A-22 Hemodialyzer Ref K992563
Regimes: 510(k) Registry: 510(k)Althin Medical Ab Altracart Ii Ref K990010
Regimes: 510(k) Registry: 510(k)Af-150 Hemodialyzer Ref K992566
Regimes: 510(k) Registry: 510(k)Af-180 Hemodialyzer Ref K992564
Regimes: 510(k) Registry: 510(k)A-18 Hemodialyzer Ref K992565
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Althin Medical AB have in the registry?
The registry currently lists 7 devices for Althin Medical AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Althin Medical AB's devices?
Among its 7 most recently registered devices, Althin Medical AB has devices listed in FDA 510(k) (7 devices).
What risk classes do Althin Medical AB's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Althin Medical AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Althin Medical AB in the registry?
The most recently registered devices listed for Althin Medical AB include AF-220 HEMODIALYZER, A-15 HEMODIALYZER, A-22 HEMODIALYZER and ALTHIN MEDICAL AB ALTRACART II.