Affinity Medical Technologies, LLC
Country not established
- Devices
- 11
What Affinity Medical Technologies, LLC makes
Affinity Medical Technologies, LLC manufactures reusable electrocardiographic lead sets, including cable and leadwire systems designed for cardiac monitoring and electrodiagnostic procedures. Their products also include specialized cables for electromyography (EMG) applications, such as nerve conduction studies. These devices are intended for use in clinical and diagnostic settings to facilitate accurate signal transmission during cardiac and neuromuscular assessments.
The company’s portfolio is regulated under Class II medical devices in the US, with products authorised through FDA pathways including the 510(k) premarket notification process and the Unique Device Identification (UDI) system. Their devices are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.
Catalogue
Search and filter all 11 devicesCompany details
- DUNS number
- 088091038
Frequently asked questions
How many devices does Affinity Medical Technologies, LLC have in the registry?
The registry currently lists 11 devices for Affinity Medical Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Affinity Medical Technologies, LLC's devices?
Among its 11 most recently registered devices, Affinity Medical Technologies, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Affinity Medical Technologies, LLC's devices fall under?
Among its 11 most recently registered devices, the classes recorded for Affinity Medical Technologies, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Affinity Medical Technologies, LLC in the registry?
The most recently registered devices listed for Affinity Medical Technologies, LLC include Affinity Cable and Leadwire System T099-1 DTX, EMG Cable for Nerveäna CEMGB, Affinity Cable and Leadwire System 394111-009 and Affinity Cable and Leadwire System T097-1 DTX.