Durio Ppe Sdn Bhd
MalaysiaFDA 510(k) applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Durio Ppe Sdn Bhd makes
Durio Ppe Sdn Bhd makes surgical face masks, specifically the Durio Surgical Face Mask in models 501 (3-ply, blue) and 545 (4-ply, blue).
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
- 510(k) 510(k)
FDA establishments
- Durio Ppe Sdn. Bhd. Johor Bahru · MY FEI 3017598017
Frequently asked questions
How many devices does Durio Ppe Sdn Bhd have in the registry?
The registry currently lists 1 device for Durio Ppe Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Durio Ppe Sdn Bhd's devices?
Among its 1 most recently registered device, Durio Ppe Sdn Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Durio Ppe Sdn Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Durio Ppe Sdn Bhd's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Durio Ppe Sdn Bhd in the registry?
The most recently registered devices listed for Durio Ppe Sdn Bhd include Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply, blue).
Which FDA establishments are linked to Durio Ppe Sdn Bhd?
1 FDA establishment is linked to Durio Ppe Sdn Bhd in the registry; they are listed on the company page.