Mtre Advanced Technology, Ltd.
Country not established
- Devices
- 6
What Mtre Advanced Technology, Ltd. makes
Mtre Advanced Technology, Ltd. manufactures medical devices primarily for temperature monitoring and management, including systems like the CRITICOOL and its PRO variant, which are designed for precise thermal regulation in clinical settings. The company also produces versions of the ALLON series, such as the ALLON 2000 and ALLON 2001 (including modified and earlier iterations), which appear to serve as advanced patient monitoring or therapeutic devices for controlled environmental conditions.
These devices are classified under Class II by regulatory standards, indicating they carry moderate risk and require pre-market notification (510(k)) clearance through the FDA. The portfolio is listed under the FDA’s 510(k) registry, reflecting their authorised status for commercial distribution in the United States. The company is headquartered in the US.
Catalogue
Allon 2001 Version 5 Ref K024128
Regimes: 510(k) Registry: 510(k)Allon 2000 Ref K992386
Regimes: 510(k) Registry: 510(k)Criticool Ref K083662
Regimes: 510(k) Registry: 510(k)Criticool Pro Ref K102112
Regimes: 510(k) Registry: 510(k)Allon 2001 Modified Ref K003349
Regimes: 510(k) Registry: 510(k)Allon 2001 Ref K001546
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mtre Advanced Technology, Ltd. have in the registry?
The registry currently lists 6 devices for Mtre Advanced Technology, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mtre Advanced Technology, Ltd.'s devices?
Among its 6 most recently registered devices, Mtre Advanced Technology, Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Mtre Advanced Technology, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Mtre Advanced Technology, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mtre Advanced Technology, Ltd. in the registry?
The most recently registered devices listed for Mtre Advanced Technology, Ltd. include ALLON 2001 VERSION 5, ALLON 2000, CRITICOOL and CRITICOOL PRO.