Identity
- Trade Name
- ComVi Biliary Stent [Full Covered-Type] EUDAMED
- Device Name
- ComVi Biliary Stent [Full Covered-Type] EUDAMED
- Model / Reference
- BC1006F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809233102718 EUDAMED
- Basic UDI-DI
- B-08809233102718 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 [Full Covered-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-08809233102718 | 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 f4baf7cd-7ad1-42b8-9e44-47eba898552b 61 fields · synced Jul 30, 2026