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Single-use Digital Flexible Ureterorenoscopes
EUDAMEDClass IIa (EU MDR)
Ref 100004431Model XY-S600-A，XY-S600-B，XY-L600-A，XY-L600-B，XY-S630-A，XY-S630-B，XY-L630-A，XY-L630-B，XY-S650-A，XY-S650-B，XY-L650-A，XY-L650-BRef XY-S650-A-0
Identity
- Trade Name
- Single-use Digital Flexible Ureterorenoscopes EUDAMEDSingle-Use Digital Flexible Ureteroscopes EUDAMED
- Device Name
- Single-use Digital Flexible Ureterorenoscopes EUDAMEDSingle-Use Digital Flexible Ureteroscopes EUDAMED
- Model / Reference
- XY-S600-A，XY-S600-B，XY-L600-A，XY-L600-B，XY-S630-A，XY-S630-B，XY-L630-A，XY-L630-B，XY-S650-A，XY-S650-B，XY-L650-A，XY-L650-B EUDAMED100004431 EUDAMEDXY-S650-A-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974529069814 EUDAMED
- Basic UDI-DI
- 697452906YSLXC EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES 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
Category: Flexible video ureteroscope, single-use
Single-use Digital Flexible Ureterorenoscopes by Ningbo Xinwell Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
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 | 697452906YSLXC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Xinwell Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000001084
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED a40b0a64-8889-470d-a1ec-d9083fbad35a 61 fields · synced Jul 8, 2026
- EUDAMED b4e53470-3c1e-424d-8dd9-e46168cbb551 61 fields · synced Jul 8, 2026