HILZO Biliary Stent System
by BCM Co., Ltd. South Korea EUDAMED
Ref RVP1008TC-I
EMDN P0502
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800026628576 | Date6 Aug 2026 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
EU market availability
Available in 19 countries, as listed in EUDAMED:
- Austriasince 3 Apr 2019
- Belgiumsince 18 Oct 2019
- Croatiasince 25 Apr 2024
- Cyprussince 20 Jun 2023
- Czechiasince 15 Jan 2019
- Denmarksince 27 Nov 2015
- Estoniasince 24 Aug 2018
- Francesince 16 Feb 2017
- Germanysince 1 Dec 2016
- Greecesince 19 Mar 2018
- Hungarysince 25 Feb 2025
- Irelandsince 11 Mar 2019
- Italysince 22 May 2017
- Netherlandssince 2 May 2016
- Norwaysince 21 Mar 2023
- Polandsince 13 Jan 2026
- Spainsince 14 Jan 2019
- Swedensince 10 Jul 2024
- Türkiyesince 19 Oct 2015
Specification
- Model / Reference
- RVP1008TC-I
- Primary DI / UDI-DI
- 08800026628576
- Basic UDI-DI
- B-08800026628576
- EMDN Code
- P0502 Biliary and pancreatic prostheses
- Device Class
- Class IIb
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- KR-MF-000017292
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Bcm Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: 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 26759fac-c7ee-49d0-b866-aae1480e63e2