Astute Medical, Inc.
Inactive in EUDAMED since 2023United Statesfrom EUDAMED address EUDAMED SRN US-MF-000009662
Inactive. This company's EUDAMED actor record is marked inactive. Check the current status before ordering.
- Devices
- 3
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Astute Medical, Inc. makes
Astute Medical, Inc. manufactures in vitro diagnostic devices for assessing kidney function, including the NEPHROCHECK Test System and associated test kits. These products are designed to measure biomarkers such as cystatin C and creatinine to evaluate acute kidney injury and monitor renal health. The portfolio also includes calibration verification kits and liquid controls for ensuring test accuracy.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) database. Astute Medical, Inc. is headquartered in the United States.
Catalogue
NEPHROCHECK Test System Ref K171482
Regimes: 510(k) Registry: 510(k)Nephrocheck Test System Ref DEN130031
Regimes: De Novo Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000009662
- EU VAT number
- 284049987
- EUDAMED status
- Inactive since 2023
- EUDAMED registered name
- Astute Medical, Inc.
- EUDAMED abbreviated name
- Astute Medical
- Website
- www.astutemedical.com
- linkedin.com/company/biomerieux
- [email protected]
- Phone
- +1 858 500 7000
- PRRC contact
- Ravi Vijayendran
From the company website
Since 1963, bioMérieux has been paving the way in the field of in vitro diagnostics and has contributed making the world a healthier place.
Frequently asked questions
How many devices does Astute Medical, Inc. have in the registry?
The registry currently lists 3 devices for Astute Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Astute Medical, Inc.'s devices?
Among its 3 most recently registered devices, Astute Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Astute Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Astute Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Astute Medical, Inc. in the registry?
The most recently registered devices listed for Astute Medical, Inc. include NEPHROCHECK Test System and NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit.