Asterasys Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 5
What Asterasys Co., Ltd. makes
Asterasys Co., Ltd. manufactures the Coolfase, a device designed for temperature-controlled medical applications, likely used in procedures requiring precise thermal management.
The Coolfase is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Coolfase Ref K250852
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 689846833
- [email protected]
- Phone
- +8218337010
Frequently asked questions
How many devices does Asterasys Co., Ltd. have in the registry?
The registry currently lists 5 devices for Asterasys Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Asterasys Co., Ltd.'s devices?
Among its 5 most recently registered devices, Asterasys Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Asterasys Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Asterasys Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Asterasys Co., Ltd. in the registry?
The most recently registered devices listed for Asterasys Co., Ltd. include Coolfase CF-GP01, Coolfase Coupling Fluid, Coolfase and Coolfase CF-CT20M-SB.