Dentsleeve Pty., Ltd.
Country not established
- Devices
- 3
What Dentsleeve Pty., Ltd. makes
Dentsleeve Pty., Ltd. manufactures manometric perfusion pumps and related manometric assemblies, including models designed for CO₂ flushing. These devices are used in medical procedures requiring precise fluid delivery and pressure monitoring, such as ophthalmic surgeries.
The company’s portfolio is regulated under FDA Class II devices and is listed via 510(k) premarket notifications. Products are based in the US and comply with applicable US regulatory requirements.
Catalogue
Mark Ii/Mark Iii Manometric Perfusion Pump Ref K013154
Regimes: 510(k) Registry: 510(k)Manometric Assemblies Ref K983665
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dentsleeve Pty., Ltd. have in the registry?
The registry currently lists 3 devices for Dentsleeve Pty., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dentsleeve Pty., Ltd.'s devices?
Among its 3 most recently registered devices, Dentsleeve Pty., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Dentsleeve Pty., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Dentsleeve Pty., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dentsleeve Pty., Ltd. in the registry?
The most recently registered devices listed for Dentsleeve Pty., Ltd. include MARK II/MARK III MANOMETRIC PERFUSION PUMP, MANOMETRIC ASSEMBLIES and MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP.