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Single-Use Cysto-Nephroscope

EUDAMED

Class IIa (EU MDR)

Ref \Model FCY08-L069BAF

by Wuhan Mindray Scientific Co., Ltd.

Identity

Device Name
Single-Use Cysto-Nephroscope EUDAMED
Model / Reference
FCY08-L069BAF EUDAMED
\ EUDAMED

Identifiers

Primary DI / UDI-DI
06903053111614 EUDAMED
Basic UDI-DI
697728811A065000219C EUDAMED
EMDN Code
Z12020711 VIDEO CYSTOURETHROSCOPES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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 Cysto-Nephroscope by Wuhan Mindray Scientific 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-000032692
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 4c73e4ce-ce48-4aa5-84eb-ffb6b4d89e0f 61 fields · synced Jun 19, 2026