REMEDI Inc.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000026327 FEI 3013779985
REMEDI Inc. is a medical device manufacturer based in South Korea, with 5 devices listed in EUDAMED, FDA 510(k) and FDA GUDID (EU Class IIb; FDA Class II) as of 15 Nov 2026.
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 3
- FDA 510(k) 2
- FDA GUDID 1
- Device classes
- EU Class IIb 3
- FDA Class II 2
- Top EMDN categories
- Sites and related companies
- JaviTech e.K. authorised representative
- Identifiers
- EUDAMED SRN KR-MF-000026327
- FDA FEI 3013779985
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- JaviTech e.K.DE
Catalogue
Remex-T(K)100C Ref K261943
Regimes: 510(k) Registry: 510(k)REMEX Xcam6 Ref K250597
Regimes: 510(k) Registry: 510(k)Remex-K100 Ref REM-IFU-T(K)100
Regimes: CE MDD Registry: EUDAMEDStationary Anode X-ray tube Ref REM-IFU-RMT08
Regimes: CE MDD Registry: EUDAMEDPortable X-ray equipment Ref REM-IFU-T(K)100_Instruction For Use
Regimes: CE MDD Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- KR-MF-000026327
- FDA FEI number
- 3013779985
- EUDAMED status
- Active
- EUDAMED registered name
- REMEDI Inc.
- EUDAMED abbreviated name
- REMEDI
- Registered address
- 69-14, Sakju-ro 145beon-gil, 24232, Chuncheon-si, Gangwon-do, South Korea
- Website
- www.remedihc.com
- sales@remedihc.com
- Phone
- +82 2 6930 5891
- PRRC contact
- SeongGeun Park
FDA establishments
- Remedi Co., Ltd. US
Frequently asked questions
How many devices does REMEDI Inc. have in the registry?
The registry currently lists 5 devices for REMEDI Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list REMEDI Inc.'s devices?
Among its 5 most recently registered devices, REMEDI Inc. has devices listed in EUDAMED (3 devices), 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 REMEDI Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for REMEDI Inc.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from REMEDI Inc. in the registry?
The most recently registered devices listed for REMEDI Inc. include REMEX-T(K)100C, REMEX Xcam6, REMEX-K100 and Stationary Anode X-ray tube.
Which FDA establishments are linked to REMEDI Inc.?
1 FDA establishment is linked to REMEDI Inc. in the registry; they are listed on the company page.