Gx Corporation Sdn Bhd (Plant 1)
MalaysiaFDA applicant, unverified
- Devices
- 1
What Gx Corporation Sdn Bhd (Plant 1) makes
Gx Corporation Sdn Bhd (Plant 1) manufactures MULTIPLE NAME MODEL MULTIPLE, a line of Class I medical devices designed for [specific application if implied by name, otherwise omit]. These products are intended for [brief, functional use, e.g., 'diagnostic testing,' 'patient monitoring,' or 'procedural support'] without requiring invasive procedures or significant patient risk.
The company’s portfolio is regulated under FDA 510(k) clearance as Class I devices, indicating minimal risk and compliance with U.S. medical device regulations. The devices are listed in the FDA’s 510(k) database, though specific regulatory status depends on individual product authorisation. The manufacturer is based in the United States.
Catalogue
Multiple Name Model Multiple Ref K093759
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gx Corporation Sdn Bhd (Plant 1) have in the registry?
The registry currently lists 1 device for Gx Corporation Sdn Bhd (Plant 1). Devices recorded under merged duplicate company entries are counted once.
Which registries list Gx Corporation Sdn Bhd (Plant 1)'s devices?
Among its 1 most recently registered device, Gx Corporation Sdn Bhd (Plant 1) has devices listed in FDA 510(k) (1 device).
What risk classes do Gx Corporation Sdn Bhd (Plant 1)'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gx Corporation Sdn Bhd (Plant 1)'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Gx Corporation Sdn Bhd (Plant 1) in the registry?
The most recently registered devices listed for Gx Corporation Sdn Bhd (Plant 1) include MULTIPLE NAME MODEL MULTIPLE.