Dolomite Biotech Sdn Bhd
Country not established
- Devices
- 1
What Dolomite Biotech Sdn Bhd makes
Dolomite Biotech Sdn Bhd manufactures the SSAFE PLUS disposable safety syringe in 3 cc and 5 cc sizes, designed for single-use medical injections to enhance user safety by reducing needle-stick injuries.
The company’s products are regulated as Class II devices under the FDA’s 510(k) pathway and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- 510(k) 510(k)
Frequently asked questions
How many devices does Dolomite Biotech Sdn Bhd have in the registry?
The registry currently lists 1 device for Dolomite Biotech Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dolomite Biotech Sdn Bhd's devices?
Among its 1 most recently registered device, Dolomite Biotech Sdn Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Dolomite Biotech Sdn Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Dolomite Biotech Sdn Bhd's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dolomite Biotech Sdn Bhd in the registry?
The most recently registered devices listed for Dolomite Biotech Sdn Bhd include SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC.