Identity
- Trade Name
- ComVi Biliary Stent [Both Bare-Type] EUDAMED
- Device Name
- ComVi Biliary Stent [Both Bare-Type] EUDAMED
- Model / Reference
- BC0806B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809233102824 EUDAMED
- Basic UDI-DI
- B-08809233102824 EUDAMED
- EMDN Code
- P0502 BILIARY AND PANCREATIC PROSTHESES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ComVi Biliary Stent [Both Bare-Type] by Taewoong Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809233102824 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Taewoong Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000007515
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 95d9a841-d945-4267-affc-640112f194be 61 fields · synced Aug 4, 2026