Tns Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 2
What Tns Co., Ltd. makes
Tns Co., Ltd. manufactures the Serafin®, a medical device designed for use in specific diagnostic or therapeutic procedures. The product appears to be a Class II device, indicating it is subject to performance-based regulations and requires pre-market notification (510(k)) clearance in the United States.
The Serafin® is regulated as a Class II device under the FDA’s 510(k) pathway, ensuring compliance with U.S. medical device regulations. The company is based in the United States and has its devices listed in the FDA’s 510(k) clearance registry.
Catalogue
Frequently asked questions
How many devices does Tns Co., Ltd. have in the registry?
The registry currently lists 2 devices for Tns Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tns Co., Ltd.'s devices?
Among its 2 most recently registered devices, Tns Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Tns Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Tns Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tns Co., Ltd. in the registry?
The most recently registered devices listed for Tns Co., Ltd. include Serafin®.