Identity
- Trade Name
- Niti-S Biliary Covered Stent [Giobor] EUDAMED
- Device Name
- Niti-S Biliary Covered Stent [Giobor] EUDAMED
- Model / Reference
- BS0808FP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809233109762 EUDAMED
- Basic UDI-DI
- B-08809233109762 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
Niti-S Biliary Covered Stent [Giobor] 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-08809233109762 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Taewoong Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000007515
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 673a4606-942e-4f8b-800f-ff1c41aa0b6c 61 fields · synced Oct 7, 2026