EdgeCare Inc.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000039973 FEI 3031569584
- Devices
- 9
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- CMC Medical Devices & Drugs SLES
What EdgeCare Inc. makes
EdgeCare Inc. manufactures wound care products, including the EdgeFlow Gel Pad for moist wound healing and a series of EdgeFlow devices (UW20, UH10L, UH10, UH10S) designed for negative pressure wound therapy (NPWT) applications.
These devices are classified as Class II and Class IIa under EU and FDA regulations, with listings in the EUDAMED database and FDA’s 510(k) registry. The company is based in South Korea.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
EdgeFlow Gel Pad Ref K252337
Regimes: 510(k) Registry: 510(k)EdgeFlow UW20 Ref K252237
Regimes: 510(k) Registry: 510(k)EdgeFlow UH10L Ref UH10101L
Regimes: CE MDR Registry: EUDAMEDGUDIDEdgeFlow UH10 Ref UH10101
Regimes: CE MDR 510(k) Registry: EUDAMEDGUDIDEdgeFlow UH10S Ref UH10101S
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- KR-MF-000039973
- FDA FEI number
- 3031569584
- DUNS number
- 695523164
- EUDAMED status
- Active
- EUDAMED registered name
- Edgecare Inc.
- Registered address
- 8, Yangpyeong-ro 25-gil, 07207, Seoul, South Korea
- Website
- www.edgecare.co.kr
- [email protected]
- Phone
- +82 1577 9796
- PRRC contact
- Honggeun Jung
Frequently asked questions
How many devices does EdgeCare Inc. have in the registry?
The registry currently lists 9 devices for EdgeCare Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list EdgeCare Inc.'s devices?
Among its 9 most recently registered devices, EdgeCare Inc. has devices listed in EUDAMED (3 devices), FDA 510(k) (2 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do EdgeCare Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for EdgeCare Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from EdgeCare Inc. in the registry?
The most recently registered devices listed for EdgeCare Inc. include EdgeFlow UH10E UH10101E, EdgeFlow UH10C UH10101C, EdgeFlow Gel Pad 00274 and EdgeFlow UW20 UW20101.