Duodenal/Pyloric Stent with Delivery System
by M.I.Tech Co., Ltd South Korea EUDAMED
Ref NDSL-22-170-120Model HANAROSTENT® Duodenum/Pylorus Lasso (NNN)
EMDN P0503
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88063670DUON002U6 | Date21 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- G70 080984 0025 Supplemented
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 9 Jul 2026
- Expires
- 30 Aug 2028
- Reason
- Add device or group
Specification
- Device Name
- Duodenal/Pyloric Stent with Delivery System
- Model / Reference
- HANAROSTENT® Duodenum/Pylorus Lasso (NNN), NDSL-22-170-120
- Primary DI / UDI-DI
- 08806367005151
- Basic UDI-DI
- 88063670DUON002U6
- EMDN Code
- P0503 Colonic and duodenal 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 (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 08806367005151|88063670DUON002U6