Bontech, Inc.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000048185
Part of BONTECH Co., Ltd.
- Devices
- 10
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
- GUDID
Bt-DB22-Ia Ref BT-DMF-005
CE MDR EUDAMEDGUDIDBSD4343 Digital Flat Panel X-ray Detector Ref K160204
510(k) 510(k)BSD3543 Digital Flat Panel X-ray Detector Ref K162487
510(k) 510(k)BSD4343R Digital Flat Panel X-ray Detector Ref K171485
510(k) 510(k)Bt-DA24-Ia Ref BT-DMF-002
CE MDR EUDAMEDGUDIDBT-DA12M, Pinkview-UPS Ref BT-DMF-008
CE MDR EUDAMEDBt-DA22-Ia Ref BT-DMF-003
CE MDR EUDAMEDGUDIDBt-DB24-Ia Ref BT-DMF-004
CE MDR EUDAMEDGUDIDBt-DA22W Ref BT-DMF-006
CE MDR EUDAMEDGUDID
Company details
- EUDAMED SRN
- KR-MF-000048185
- DUNS number
- 689050426
- EUDAMED status
- Active
- EUDAMED registered name
- BONTECH Co., Ltd.
- Registered address
- 16690, Suwon-si, Gyeonggi-do, South Korea
- Website
- www.bontech1.com
- [email protected]
- Phone
- +82-31-303-5254
- PRRC contact
- Jua Kim
Frequently asked questions
How many devices does Bontech, Inc. have in the registry?
The registry currently lists 10 devices for Bontech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bontech, Inc.'s devices?
Among its 10 most recently registered devices, Bontech, Inc. has devices listed in EUDAMED (6 devices), FDA 510(k) (3 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bontech, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Bontech, Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bontech, Inc. in the registry?
The most recently registered devices listed for Bontech, Inc. include BONX805, DIONE-X80 Portable X-ray Imaging Device, BT-DB22-IA, BSD4343 Digital Flat Panel X-ray Detector and BSD3543 Digital Flat Panel X-ray Detector.