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4K Medical Endoscopic Camera System

EUDAMED

Class I (EU MDR)

Ref wDubhe V40AModel wMerak 40u, wlerak 40p, wMerak 40a, wMlerak40g, wMerak40s, wMerak 40e, wMerak40c, wMerak40b, wDubhe V40A, wDubhe V40B、wDubhe V40C、wDubhe V40D, wDubhe V40E、wDubhe V40F

by Weyo Surgical Technology Ltd.

Identity

Trade Name
4K Medical Endoscopic Camera System EUDAMED
Device Name
4K Medical Endoscopic Camera System EUDAMED
Model / Reference
wMerak 40u, wlerak 40p, wMerak 40a, wMlerak40g, wMerak40s, wMerak 40e, wMerak40c, wMerak40b, wDubhe V40A, wDubhe V40B、wDubhe V40C、wDubhe V40D, wDubhe V40E、wDubhe V40F EUDAMED
wDubhe V40A EUDAMED

Identifiers

Primary DI / UDI-DI
06975621670274 EUDAMED
Basic UDI-DI
697562167Z120204010187 EUDAMED
EMDN Code
Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

4K Medical Endoscopic Camera System by Weyo Surgical Technology Ltd. — Class I — 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

Manufacturer
Weyo Surgical Technology Ltd.
EUDAMED SRN
CN-MF-000038773
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED d463ebac-1670-45e5-bb38-dd10b3a0619b 61 fields · synced Jun 20, 2026