feel-DRCS
Ref IFU001
Withdrawn
CE MDD, withdrawn
Ended
Withdrawn
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800158200015 08800158200015 | Date16 May 2025 | StatusWithdrawn |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Withdrawn
Specification
- Device Name
- Radiological Image Processing System (feel-DRCS)
- Model / Reference
- IFU001
- Primary DI / UDI-DI
- 08800158200015
- Basic UDI-DI
- B-08800158200015
- EMDN Code
- Z11031192 Systems for direct digital radiology (dr) - medical device software
- Device Class
- Class IIb
- Special Device Type
- -1192
Manufacturer details
- EUDAMED SRN
- KR-MF-000043143
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Imfou Co., Ltd.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No