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MonoStereo Visualization system

by MedicalTek Co., Ltd. 3 variants

Ref MS-3D02

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987996MonoStereo2A Basic UDI-DI 04719879963021UDI-DIDate25 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
MonoStereo Visualization system
Model / Reference
MS-3D02
Primary DI / UDI-DI
04719879963021
Basic UDI-DI
471987996MonoStereo2A
Direct Marketing DI
04719879963021
EMDN Code
Z12020499 Instruments for the acquisition and management of endoscopic and minimally invasive surgery images – other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000014722
Authorised representative
KOMAS Medical Technology GmbH DE-AR-000045617

Other devices from MedicalTek Co., Ltd.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: 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