Regalfield Sdn. Bhd.
MalaysiaFDA applicant, unverified
- Devices
- 1
What Regalfield Sdn. Bhd. makes
Regalfield Sdn. Bhd. manufactures MEDTEXX, a Class I medical device designed for [specific application not provided in data]. The product is intended for [purpose not detailed in data], adhering to regulatory standards for low-risk devices.
MEDTEXX is regulated under the FDA’s 510(k) pathway as a Class I device and is listed in the FDA’s 510(k) database. The company is based in the US.
Catalogue
Medtexx Ref K963331
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Regalfield Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Regalfield Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Regalfield Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Regalfield Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Regalfield Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Regalfield Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Regalfield Sdn. Bhd. in the registry?
The most recently registered devices listed for Regalfield Sdn. Bhd. include MEDTEXX.