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Single-use Digital Flexible Cystoscopes
EUDAMEDClass IIa (EU MDR)
Ref XY-SC42S-0R-0Model XY-SC42S-0S, XY-SC42S-1S, XY-SC42S-0R, XY-SC42S-1R, XY-SC54S-0S, XY-SC54S-1S, XY-SC54S-0R, XY-SC54S-1R
Identity
- Trade Name
- Single-use Digital Flexible Cystoscopes EUDAMED
- Device Name
- Single-use Digital Flexible Cystoscopes EUDAMED
- Model / Reference
- XY-SC42S-0S, XY-SC42S-1S, XY-SC42S-0R, XY-SC42S-1R, XY-SC54S-0S, XY-SC54S-1S, XY-SC54S-0R, XY-SC54S-1R EUDAMEDXY-SC42S-0R-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942067977885 EUDAMED
- Basic UDI-DI
- 69420679SCFA EUDAMED
- EMDN Code
- Z12020701 CYSTOSCOPES 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 Cystoscopes by Ningbo Xinwell 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 | 69420679SCFA | 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 (1)
- EUDAMED 30fc04e8-8842-4125-b83a-659326ddd8f9 61 fields · synced Aug 5, 2026