Duodenal/Pyloric Stent with Delivery System
by M.I.Tech Co., Ltd 455 variants
Ref NDS-18-070-230Model HANAROSTENT® Duodenum/Pylorus (NNN)
Active
CE MDR
Valid until
30 Aug 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88063670DUON001U4 08806367004765 | Date29 Sep 2026 | StatusActive |
Certificates
- G70 080984 0025 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 9 Jul 2026
- Expires
- 30 Aug 2028
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Duodenal/Pyloric Stent with Delivery System
- Model / Reference
- HANAROSTENT® Duodenum/Pylorus (NNN), NDS-18-070-230
- Primary DI / UDI-DI
- 08806367004765
- Basic UDI-DI
- 88063670DUON001U4
- EMDN Code
- P0503 Colonic and duodenal prostheses
- Device Class
- Class IIb
- EU 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
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