Kolvin Industries, Ltd.
Hong Kong SAR ChinaFDA 510(k) applicant, unverified
- Devices
- 2
What Kolvin Industries, Ltd. makes
Kolvin Industries manufactures a range of Class I medical devices, including diagnostic radiography units (e.g., DR-3, DR-6, DR-68, DR-88) and dental X-ray machines (e.g., DH-1, DH-2, DH-3, DH-6, DH-68). The portfolio also includes dental film processing systems (e.g., FM-10, FM-20, FM-30) and automated dental X-ray processors (e.g., AMH-6, FBM-1000, FBM-2000).
These devices are regulated under the US FDA’s 510(k) pathway as Class I medical devices and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Dr-3, Dr-6, Dr-68, Dr-88, Amr-6, Fr-22R, Dr-22B Ref K944884
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Kolvin Industries, Ltd. have in the registry?
The registry currently lists 2 devices for Kolvin Industries, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kolvin Industries, Ltd.'s devices?
Among its 2 most recently registered devices, Kolvin Industries, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Kolvin Industries, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Kolvin Industries, Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Kolvin Industries, Ltd. in the registry?
The most recently registered devices listed for Kolvin Industries, Ltd. include DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B and DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000.