Hanarostent®
by M.I.Tech Co., Ltd South Korea EUDAMED
Ref HEVT-22-120-070Model CHOOSTENT® Esophagus Valve ST (CCN)
EMDN P050101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08806367016461 | Date3 Aug 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Esophageal Stent with Delivery System
- Model / Reference
- CHOOSTENT® Esophagus Valve ST (CCN), HEVT-22-120-070
- Primary DI / UDI-DI
- 08806367016461
- Basic UDI-DI
- B-08806367016461
- EMDN Code
- P050101 Gastro-esophageal reflux correction prostheses
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000011623
- Authorised representative
- KTR Europe GmbH DE-AR-000005685
Other devices from M.I.Tech Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- 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
Sources (1)
- EUDAMED ddde1aeb-b90e-4888-b8ff-c9ddf451bfa0