No Certificate Found

Snapshot 2026-10-12 · Link to EUDAMED

Single-use Digital Flexible Cystoscopes

UDI-DI 06942067977922Basic UDI-DI 69420679SCFA

Class IIa · MDR · Ningbo Xinwell Medical Technology Co., Ltd

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Identification

Model: XY-SC42S-0S, XY-SC42S-1S, XY-SC42S-0R, XY-SC42S-1R, XY-SC54S-0S, XY-SC54S-1S, XY-SC54S-0R, XY-SC54S-1R
EMDN: Z12020701
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-12 · Link to EUDAMED

Manufacturer

Ningbo Xinwell Medical Technology Co., Ltd

SRN CN-MF-000001084

CN · Cixi, Zhejiang

manufacturer

Authorised representative: Lotus NL B.V. (NL-AR-000000121)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/single-use-digital-flexible-cystoscopes-7922 · UDI page: /udi/06942067977922

All devices from Ningbo Xinwell Medical Technology Co., Ltd

Scan an inventory CSV