Axiom Ent. Co., Ltd.
TaiwanFDA 510(k) applicant, unverified
- Devices
- 1
What Axiom Ent. Co., Ltd. makes
Axiom Ent. Co., Ltd. manufactures the AXIOM and SUNFAST devices, which are designed for specific medical applications within Class I categories. These products are intended for use in clinical or procedural settings where low-risk, non-invasive or minimally invasive interventions are required.
The company’s portfolio is regulated under the FDA’s 510(k) pathway, with devices classified as Class I. These products are listed in the FDA’s regulatory database, adhering to U.S. medical device compliance standards. The company is headquartered in the United States.
Catalogue
Axiom, Sunfast Ref K944915
510(k) 510(k)
Frequently asked questions
How many devices does Axiom Ent. Co., Ltd. have in the registry?
The registry currently lists 1 device for Axiom Ent. Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Axiom Ent. Co., Ltd.'s devices?
Among its 1 most recently registered device, Axiom Ent. Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Axiom Ent. Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Axiom Ent. Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Axiom Ent. Co., Ltd. in the registry?
The most recently registered devices listed for Axiom Ent. Co., Ltd. include AXIOM, SUNFAST.