Imfou Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000043143
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Imfou Co., Ltd. makes
Imfou Co., Ltd. manufactures the FEEL-DRCS, a device designed for deep rectal cancer staging and treatment planning using magnetic resonance imaging (MRI) guidance.
The FEEL-DRCS is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Company details
- EUDAMED SRN
- KR-MF-000043143
- EU VAT number
- 119-86-18695
- EUDAMED status
- Active
- EUDAMED registered name
- IMFOU Co., Ltd.
- Registered address
- Digital-ro 33-gil (Room No. 1105, Daerung Post Tower 7th), Guro-gu, 48, Seoul, South Korea
- [email protected]
- PRRC contact
- Kim Junwoo
FDA establishments
- imfoU CO., LTD Guro-gu Seoul · KR FEI 3009463023
Frequently asked questions
How many devices does Imfou Co., Ltd. have in the registry?
The registry currently lists 2 devices for Imfou Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Imfou Co., Ltd.'s devices?
Among its 2 most recently registered devices, Imfou Co., Ltd. has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Imfou Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Imfou Co., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Imfou Co., Ltd. in the registry?
The most recently registered devices listed for Imfou Co., Ltd. include feel-DRCS.
Which FDA establishments are linked to Imfou Co., Ltd.?
1 FDA establishment is linked to Imfou Co., Ltd. in the registry; they are listed on the company page.