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Single-use flexible cystoscope
EUDAMEDClass IIa (EU MDR)
Ref SUV-4D-BModel SUV-1D-B, SUV-1D-P, SUV-3D-B, SUV-4D-BRef SUV-1D-B
Identity
- Trade Name
- Single-use flexible cystoscope EUDAMED
- Device Name
- Single-use flexible cystoscope EUDAMED
- Model / Reference
- SUV-1D-B, SUV-1D-P, SUV-3D-B, SUV-4D-B EUDAMEDSUV-4D-B EUDAMEDSUV-1D-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381254853 EUDAMED06971381254273 EUDAMED
- Basic UDI-DI
- 697138125041A8K EUDAMED
- Direct Marketing DI
- 06971381254273 EUDAMED
- EMDN Code
- Z12020701 CYSTOSCOPES 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 flexible cystoscope 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 | 697138125041A8K | 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 (2)
- EUDAMED 32b21e34-4ee4-4161-ba03-0847a12c0a57 61 fields · synced Jul 22, 2026
- EUDAMED f744ff0c-9715-4e8b-b88e-6c0faa4fd0fc 61 fields · synced May 18, 2026