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Single-use Video Cholangioscope
EUDAMEDClass IIa (EU MDR)
Ref SCV-P-04GModel SCV-P-01G，SCV-P-02G，SCV-P-03G，SCV-P-04G，SCV-P-05G
Identity
- Trade Name
- Single-use Video Cholangioscope EUDAMED
- Device Name
- Single-use Video Cholangioscope EUDAMED
- Model / Reference
- SCV-P-01G，SCV-P-02G，SCV-P-03G，SCV-P-04G，SCV-P-05G EUDAMEDSCV-P-04G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381256963 EUDAMED
- Basic UDI-DI
- 697138125031A8E EUDAMED
- EMDN Code
- Z12020501 CHOLEDOCOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Single-use Video Cholangioscope by Scivita Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697138125031A8E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c91fcce7-668f-4cf9-ba80-ef2107ea6d9f 61 fields · synced May 23, 2026