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Single-use Flexible Ureteroscope
EUDAMEDClass IIa (EU MDR)
Ref SUV-2A-BModel SUV-1A-B,SUV-1A-P,SUV-2A-B,SUV-2A-P,SUV-2B-B,SUV-2B-P,SUV-2C-B,SUV-2C-P,SUV-3A-B,SUV-3C-B,SUV-4A-B,SUV-4C-BRef SUV-2A-PRef SUV-2C-PRef SUV-4C-BRef SUV-2B-BRef SUV-1A-BRef SUV-2C-B
Identity
- Trade Name
- Single-use Flexible Ureteroscope EUDAMED
- Device Name
- Single-use Flexible Ureteroscope EUDAMED
- Model / Reference
- SUV-1A-B,SUV-1A-P,SUV-2A-B,SUV-2A-P,SUV-2B-B,SUV-2B-P,SUV-2C-B,SUV-2C-P,SUV-3A-B,SUV-3C-B,SUV-4A-B,SUV-4C-B EUDAMEDSUV-2A-B EUDAMEDSUV-2A-P EUDAMEDSUV-2C-P EUDAMEDSUV-4C-B EUDAMEDSUV-2B-B EUDAMEDSUV-1A-B EUDAMEDSUV-2C-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381250381 EUDAMED06971381250435 EUDAMED06971381254266 EUDAMED06971381254839 EUDAMED06971381250398 EUDAMED06971381254198 EUDAMED06971381254228 EUDAMED
- Basic UDI-DI
- 697138125007A8H EUDAMED
- Direct Marketing DI
- 06971381250381 EUDAMED06971381250435 EUDAMED06971381254266 EUDAMED06971381254839 EUDAMED06971381250398 EUDAMED06971381254198 EUDAMED06971381254228 EUDAMED
- EMDN Code
- Z12020709 UTEROSCOPES EUDAMEDZ12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDBelgium 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 Ureteroscope 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 | 697138125007A8H | 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 (7)
- EUDAMED 4bd3f461-5a44-46b0-a16b-5de09e290d1f 61 fields · synced Aug 3, 2026
- EUDAMED ebef209c-1a37-427f-827d-f5314ccd5afe 61 fields · synced May 17, 2026
- EUDAMED 8d72d27f-3e62-413d-97f3-fdbc0731d7bd 61 fields · synced May 17, 2026
- EUDAMED 97af485b-ec1c-4bf1-a4e6-18f7bbe4e87f 61 fields · synced May 17, 2026
- EUDAMED e335e988-5016-4b7e-a62f-7ea0801427fc 61 fields · synced May 18, 2026
- EUDAMED fe51493d-e018-4200-9c56-a4da82d3aeae 61 fields · synced May 18, 2026
- EUDAMED b91d9c3b-aa94-409e-9dbd-158aae8e9161 61 fields · synced Aug 3, 2026