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Single-use Digital Flexible Ureterorenoscopes

EUDAMED

Class IIa (EU MDR)

Ref 100004423Model 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

by Ningbo Xinwell Medical Technology Co., Ltd

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 EUDAMED
100004423 EUDAMED

Identifiers

Primary DI / UDI-DI
06974529069739 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.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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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 8604d401-5835-4806-82a8-c1f666227a6d 61 fields · synced Jun 19, 2026