← Back to catalogue
Single-use Digital Flexible Ureterorenoscopes
EUDAMEDClass IIa (EU MDR)
Ref 100004426Model 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 100004429Ref 100004428Ref 100004430Ref 100004424Ref 100004425
Identity
- Trade Name
- Single-use Digital Flexible Ureterorenoscopes EUDAMED
- Device Name
- Single-use Digital Flexible Ureterorenoscopes 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 EUDAMED100004426 EUDAMED100004429 EUDAMED100004428 EUDAMED100004430 EUDAMED100004424 EUDAMED100004425 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974529069760 EUDAMED06974529069791 EUDAMED06974529069784 EUDAMED06974529069807 EUDAMED06974529069746 EUDAMED06974529069753 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
Single-use Digital Flexible Ureterorenoscopes by Ningbo Xinwell Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo Xinwell Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000001084
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 3cfa11cc-6202-4e25-8ef2-da8d6361b5aa 61 fields · synced Aug 2, 2026
- EUDAMED fe5f6c2c-84f2-4151-b14e-52d28aded3a3 61 fields · synced May 17, 2026
- EUDAMED 387b5716-9592-4232-9d78-c8febc9339ee 61 fields · synced May 18, 2026
- EUDAMED f7751f8b-67b5-4166-adb5-c34a9a808a56 61 fields · synced May 18, 2026
- EUDAMED e2505961-0dc3-48be-923c-8141d6356e40 61 fields · synced May 18, 2026
- EUDAMED da00a932-adbc-48c3-8797-063a34d28c22 61 fields · synced May 18, 2026