R-Group Intl.
Country not established
- Devices
- 7
What R-Group Intl. makes
R-Group Intl. manufactures single-use and reusable medical devices for vascular access and electrocardiogram monitoring, including arterial extension sets, puncture needles, infusion administration sets, and coiled extension lines. Their portfolio also covers fluid delivery systems and reusable ball-and-loop ECG electrodes designed for clinical and procedural use.
The company’s devices are classified under FDA’s Class I and Class II categories, with records submitted via the 510(k) pathway. Products are listed in the FDA’s regulatory database, and the manufacturer operates from the United States.
Catalogue
Acti-Flex Low, Medium, Rescare I, Rescare Ii. Ref K952470
510(k) 510(k)- 510(k) 510(k)
Acti-Flex Arterial Extension Set Ref K954035
510(k) 510(k)R-Group Intl. One Wall Puncture Needle Ref K913267
510(k) 510(k)Disposable And Reusable Ball And Loop Electrodes Ref K993777
510(k) 510(k)Acti-Flex Iv Administration Set Ref K001599
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does R-Group Intl. have in the registry?
The registry currently lists 7 devices for R-Group Intl.. Devices recorded under merged duplicate company entries are counted once.
Which registries list R-Group Intl.'s devices?
Among its 7 most recently registered devices, R-Group Intl. has devices listed in FDA 510(k) (7 devices).
What risk classes do R-Group Intl.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for R-Group Intl.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from R-Group Intl. in the registry?
The most recently registered devices listed for R-Group Intl. include ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II., ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S, ACTI-FLEX ARTERIAL EXTENSION SET and R-GROUP INTL. ONE WALL PUNCTURE NEEDLE.