Reka Pte, Ltd.
Country not established
- Devices
- 1
What Reka Pte, Ltd. makes
Reka Pte, Ltd. manufactures the REKA E100, a medical device designed for electrophysiological mapping and ablation procedures in cardiac electrophysiology.
The REKA E100 is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Reka E100 Ref K111438
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Reka Pte, Ltd. have in the registry?
The registry currently lists 1 device for Reka Pte, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Reka Pte, Ltd.'s devices?
Among its 1 most recently registered device, Reka Pte, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Reka Pte, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Reka Pte, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Reka Pte, Ltd. in the registry?
The most recently registered devices listed for Reka Pte, Ltd. include REKA E100.