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Single-use Choledocho Videoscope
EUDAMEDClass IIa (EU MDR)
Ref SCV-BA2Model SCV-BA1 、SCV-BA2 、SCV-PA1 、SCV-PA2Ref SCV-PA2Ref SCV-PA1
Identity
- Trade Name
- Single-use Choledocho Videoscope EUDAMED
- Device Name
- Single-use Choledocho Videoscope EUDAMED
- Model / Reference
- SCV-BA1 、SCV-BA2 、SCV-PA1 、SCV-PA2 EUDAMEDSCV-BA2 EUDAMEDSCV-PA2 EUDAMEDSCV-PA1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381254365 EUDAMED06971381254389 EUDAMED06971381254372 EUDAMED
- Basic UDI-DI
- 697138125011A84 EUDAMED
- EMDN Code
- Z12020501 CHOLEDOCOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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 Choledocho Videoscope 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 | 697138125011A84 | 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 (3)
- EUDAMED fb50a891-3df5-4dc1-a238-2088e6c2b2d3 61 fields · synced Jul 19, 2026
- EUDAMED 37148446-251c-4091-b3dd-b78b3fec128d 61 fields · synced May 17, 2026
- EUDAMED 787fc55a-e177-427c-b1a3-0aad6270bf03 61 fields · synced May 17, 2026