FCU Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000015583 FEI 3017955833
- Devices
- 3
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- eZono AGDE
Catalogue
Company details
- EUDAMED SRN
- KR-MF-000015583
- FDA FEI number
- 3017955833
- EU VAT number
- 3188104944
- EUDAMED status
- Active
- EUDAMED registered name
- FCU Co., Ltd.
- Registered address
- 2F, 62-4, Techno 1-ro, 34014, Daejeon, South Korea
- Website
- fcultrasound.com
- [email protected]
- Phone
- +82 42 936 9078
- PRRC contact
- Hyuk Song
Frequently asked questions
How many devices does FCU Co., Ltd. have in the registry?
The registry currently lists 3 devices for FCU Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list FCU Co., Ltd.'s devices?
Among its 3 most recently registered devices, FCU Co., Ltd. has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do FCU Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for FCU Co., Ltd.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from FCU Co., Ltd. in the registry?
The most recently registered devices listed for FCU Co., Ltd. include SC1 Handheld Ultrasound Imaging system (Model: SC1) and Sonovation1L, SOFRA1L, SonoInfra1L, Dr.SAFE, ACUFRIEND, ACUGUIDE, ACUWARY, AcuViz Pocket, Sono Cloud 1, eZono1000, eZ1L.