Astra Meditec AB
SwedenFDA applicant, unverified
- Devices
- 3
What Astra Meditec AB makes
Astra Meditec AB manufactures dental implant systems, including the Astra Dental Implant System, which provides solutions for osseointegrated dental restoration. The company also produces wound management devices such as LOFRIC, LOFRIC CATH-KIT, ABDOVAC, BELLOVAC, and EXUDRAIN, designed for drainage and vacuum-assisted wound therapy.
The portfolio includes devices classified under Class I and Class II, with several products authorised via the FDA’s 510(k) pathway. Astra Meditec AB is based in the United States, and its devices are registered in the FDA’s 510(k) clearance database.
Catalogue
Lofric(R), Lofric(R) Cath-Kit Ref K896750
Regimes: 510(k) Registry: 510(k)Astra Dental Implant System Ref K882578
Regimes: 510(k) Registry: 510(k)Abdovac (Tm), Bellovac (Tm) And Exudrain Ref K920819
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Astra Meditec AB have in the registry?
The registry currently lists 3 devices for Astra Meditec AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Astra Meditec AB's devices?
Among its 3 most recently registered devices, Astra Meditec AB has devices listed in FDA 510(k) (3 devices).
What risk classes do Astra Meditec AB's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Astra Meditec AB's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Astra Meditec AB in the registry?
The most recently registered devices listed for Astra Meditec AB include LOFRIC(R), LOFRIC(R) CATH-KIT, ASTRA DENTAL IMPLANT SYSTEM and ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN.