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Sterile single-use Flexible Video Cystoscope

EUDAMED

Class IIa (EU MDR)

Ref DCYS2-223HPRModel DCYS2-222HP, DCYS2-222HPR, DCYS2-223HP, DCYS2-223HPR

by Himaging Technology (Shanghai) Co., Ltd.

Identity

Trade Name
Sterile single-use Flexible Video Cystoscope EUDAMED
Device Name
Single-use Flexible Video Cystoscope EUDAMED
Model / Reference
DCYS2-222HP, DCYS2-222HPR, DCYS2-223HP, DCYS2-223HPR EUDAMED
DCYS2-223HPR EUDAMED

Identifiers

Primary DI / UDI-DI
06974235401328 EUDAMED
Basic UDI-DI
697423540DCNSJW EUDAMED
EMDN Code
Z12020711 VIDEO CYSTOURETHROSCOPES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Belgium 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

Sterile single-use Flexible Video Cystoscope by Himaging Technology (Shanghai) 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

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Manufacturer

EUDAMED SRN
CN-MF-000028002
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED fc73b5d1-8185-4013-9c38-291a441cadbe 61 fields · synced Jul 31, 2026