Vatech Co., Ltd.
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Vatech Co., Ltd. is a medical device manufacturer, with 134 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIb and I) as of 14 Nov 2026.
- Devices
- 134
Registry facts
- Registries
- FDA GUDID 89
- FDA 510(k) 40
- EUDAMED 24
- Device classes
- FDA Class II 125
- EU Class IIb 5
- EU Class I 4
- Top EMDN categories
- Sites and related companies
- Vatech Co., Ltd. South Korea
- Identifiers
- DUNS 689229516
What Vatech Co., Ltd. makes
VATECH Co., Ltd. manufactures digital dental X-ray systems, including stationary panoramic and tomographic units like the PaX-i3D Green and VistaPano S 2.0, as well as handheld intraoral devices such as the EzRay Air W and EzRay Premium VET. Their portfolio also includes intraoral systems like the Green 16 and Green 18, designed for capturing detailed dental radiographs. Additional offerings include the ProVecta HD, a high-definition imaging solution, and the Smart Plus series for intraoral imaging.
The company’s devices are classified as Class II under regulatory frameworks, with authorisations granted through FDA 510(k) and FDA UDI listings. These products are intended for use in the United States, adhering to applicable medical device regulations. The manufacturer operates from its base in the US.
Catalogue
Search and filter all 134 devicesShowing 1-50 of 134
Company details
- DUNS number
- 689229516
Sites
- Vatech Co., Ltd. KRFEI 3004706313 9 devices
Frequently asked questions
How many devices does VATECH CO., LTD. have in the registry?
The registry currently lists 134 devices for VATECH CO., LTD.. Devices recorded under merged duplicate company entries are counted once.
Which registries list VATECH CO., LTD.'s devices?
Among its 50 most recently registered devices, VATECH CO., LTD. has devices listed in EUDAMED (14 devices), FDA 510(k) (4 devices) and FDA GUDID (38 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do VATECH CO., LTD.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for VATECH CO., LTD.'s devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from VATECH CO., LTD. in the registry?
The most recently registered devices listed for VATECH CO., LTD. include Green X 12 Plus, A-ST(M), Green X Plus and A-ST(L).