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4K Medical Endoscope Camera System

by Nonuple Medtec Co., Ltd.

Ref 4K Medical Endoscope Camera SystemModel JZ4KC-A

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6977194554kMECSYC Basic UDI-DI 06977194550014UDI-DIDate15 Aug 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
JZ4KC-A, 4K Medical Endoscope Camera System
Primary DI / UDI-DI
06977194550014
Basic UDI-DI
6977194554kMECSYC
Direct Marketing DI
06977194550014
EMDN Code
Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000048833
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No