Suzhou Kangjie Medical, Inc.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000008792
- Devices
- 21
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Kingsmead Service B.V.NL
What Suzhou Kangjie Medical, Inc. makes
Suzhou Kangjie Medical, Inc. manufactures ophthalmic diagnostic devices, including streak retinoscopes, direct ophthalmoscopes, and portable slit lamp microscopes—both digital and non-digital variants. These tools are designed for examining the eye’s internal structures, such as the retina and lens, in clinical and portable settings. The company’s products support vision screening, refractive error assessment, and detailed retinal imaging.
The company’s devices are classified under EU Class I and Class II regulations, with some models listed in the EUDAMED database and others subject to FDA 510(k) clearance in the United States. The portfolio is regulated under medical device directives applicable to diagnostic ophthalmic instruments, ensuring compliance with international standards for safety and performance.
Catalogue
Search and filter all 21 devicesCompany details
- EUDAMED SRN
- CN-MF-000008792
- EUDAMED status
- Active
- EUDAMED registered name
- Suzhou Kangjie Medical Inc.
- Registered address
- Bldg 15,No.2, Shuangma Street, 215121, Suzhou, China
- [email protected]
- PRRC contact
- Yonglin Zhu
Frequently asked questions
How many devices does Suzhou Kangjie Medical, Inc. have in the registry?
The registry currently lists 21 devices for Suzhou Kangjie Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou Kangjie Medical, Inc.'s devices?
Among its 21 most recently registered devices, Suzhou Kangjie Medical, Inc. has devices listed in EUDAMED (20 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Suzhou Kangjie Medical, Inc.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Suzhou Kangjie Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Suzhou Kangjie Medical, Inc. in the registry?
The most recently registered devices listed for Suzhou Kangjie Medical, Inc. include Slit Lamp Microscope, Direct Ophthalmoscope, Streak Retinoscope and Portable slit lamp microscope.