Diagnostica Stago S.A.S.
FranceFDA applicant, unverified
- Devices
- 3
What Diagnostica Stago S.A.S. makes
Diagnostica Stago S.A.S manufactures coagulation analyzers, including the STA- NeoPTimal, STA R MAX, STA R Max 3, and STA Compact Max 3. These devices are designed for automated blood testing to measure clotting factors and monitor conditions like hemophilia, thrombophilia, and anticoagulant therapy management.
The company’s coagulation analyzers are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The portfolio is regulated in the United States, where the manufacturer is based.
Catalogue
STA- NeoPTimal Ref K211485
Regimes: CE IVDR 510(k) Registry: 510(k)Sta R Max Ref K151867
Regimes: 510(k) Registry: 510(k)STA R Max 3, STA Compact Max 3 Ref K212183
Regimes: CE IVDR 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diagnostica Stago S.A.S have in the registry?
The registry currently lists 3 devices for Diagnostica Stago S.A.S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnostica Stago S.A.S's devices?
Among its 3 most recently registered devices, Diagnostica Stago S.A.S has devices listed in FDA 510(k) (3 devices).
What risk classes do Diagnostica Stago S.A.S's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Diagnostica Stago S.A.S's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diagnostica Stago S.A.S in the registry?
The most recently registered devices listed for Diagnostica Stago S.A.S include STA- NeoPTimal, STA R MAX and STA R Max 3, STA Compact Max 3.