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NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.

China·CN-MF-000001084

Last updated September 17, 2026

Information

Country: China
Address: No.188 Binjiang Road,Cixi High-tech Industrial Development Zone, Cixi, Zhejiang, China
Website: xinhaigroup.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Lei Xi
EUDAMED SRN: CN-MF-000001084
FDA FEI Number: 3017178358
DUNS Number: —

Catalogue (42)

Device	Model / Reference	Registries	Class	Status
Single-use Digital Flexible Cystoscopes	XY-SC42S-0R-0	EUDAMED	Class IIa	Active
Single-use Digital Flexible Cystoscopes	XY-SC54S-0R-0	EUDAMED	Class IIa	Active
Single-use Digital Flexible Cystoscopes	XY-SC54S-1R-0	EUDAMED	Class IIa	Active
Single-use Digital Flexible Cystoscopes	XY-SC54S-1S-0	EUDAMED	Class IIa	Active
Single-use Digital Flexible Cystoscopes	XY-SC54S-0S-0	EUDAMED	Class IIa	Active
Single-use Digital Flexible Cystoscopes	XY-SC42S-1R-0	EUDAMED	Class IIa	Active
Single-use Digital Flexible Ureterorenoscopes	100004427	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022120	EUDAMED	Class IIa	Active
Disposable Injection Needles	K232200	FDA 510(k)	Class II	Active
Disposable Hemostatic Clips	K232969	FDA 510(k)	Class II	Active
Disposable Core Biopsy Instruments	100022094	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022104	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022090	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022091	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022099	EUDAMED	Class IIa	Active
Single-use Digital Flexible Ureterorenoscopes	100004423	EUDAMED	Class IIa	Active
Single-use Digital Flexible Ureterorenoscopes	100004434	EUDAMED	Class IIa	Active
Disposable Dry Seal Chest Drainage Systems	AFG31-3 100003750	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022100	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022118	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100012191	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022117	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100012182	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022111	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022123	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022105	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022097	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100012185	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022093	EUDAMED	Class IIa	Active
Single-use Digital Flexible Ureterorenoscopes	100004432	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022095	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022112	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100022101	EUDAMED	Class IIa	Active
Single-use Digital Flexible Ureterorenoscopes	100004433	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100012186	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100012184	EUDAMED	Class IIa	Active
Single-use Digital Flexible Ureterorenoscopes	100004426	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100012190	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100012187	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100012189	EUDAMED	Class IIa	Active
Disposable Core Biopsy Instruments	100012188	EUDAMED	Class IIa	Active
Single-use Digital Flexible Ureterorenoscopes	100004431	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Lotus NL B.V. NL

Importers

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Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Ningbo Xinwell Medical Technology Co., Ltd. US