Simergent, LLC
United Statesfrom the FDA registration address FDA FEI 3025094646
- Devices
- 12
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Simergent, LLC makes
Simergent, LLC manufactures automated peritoneal dialysis cyclers, including the Archimedes Pro and Archimedes Standard models, along with associated disposable tubing sets for use in peritoneal dialysis treatments. These devices are designed to automate the exchange of dialysis fluid in patients with end-stage renal disease.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting regulatory compliance for these peritoneal dialysis systems.
Catalogue
Search and filter all 12 devicesCompany details
- FDA FEI number
- 3025094646
- DUNS number
- 080544574
- Address
- 11 NE 11th St, Oklahoma City, OK, 73104
Frequently asked questions
How many devices does Simergent, LLC have in the registry?
The registry currently lists 12 devices for Simergent, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Simergent, LLC's devices?
Among its 12 most recently registered devices, Simergent, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Simergent, LLC's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Simergent, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Simergent, LLC in the registry?
The most recently registered devices listed for Simergent, LLC include Archimedes Automated Peritoneal Dialysis (APD) Cycler - Pro 3014-00000-1, Archimedes Automated Peritoneal Dialysis (APD) Cycler - Standard 3014-00000-3, Archimedes Disposable Tubing Set - Pro 3014-51000-1 and Archimedes Disposable Tubing Set - Standard 3014-51000-3.