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ENT Endoscopy Visual System

by Mega Medical Co., Ltd. 2 variants

Ref ENT Endoscopy Visual System / MGSI-CA-ENT UNIT, ENT Endoscopy Visual System / MGSI-CA-VSModel NET-260SLCB(HD), NET-260SLCB, NET-260SLCB(HD), NET-260SLCB FHD, LS-PT

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-18800029902519 Basic UDI-DI Date5 Dec 2023RegisteredStatusActive

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  • Withdrawn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
Light Source for endoscope
Model / Reference
NET-260SLCB(HD), ENT Endoscopy Visual System / MGSI-CA-ENT UNIT, NET-260SLCB, NET-260SLCB FHD, LS-PT, ENT Endoscopy Visual System / MGSI-CA-VS
Primary DI / UDI-DI
18800029902519, 18800029903257
Basic UDI-DI
B-18800029902519, 88000299GTVS10PP
Direct Marketing DI
18800029902519
18800029903257
EMDN Code
Q0399 ENT devices - other
Device Class
Class I
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
KR-MF-000008718
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from Mega Medical 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