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4K Endoscopic Fluorescent Imaging System

by Nanjing Nuoyuan Medical Devices Co., Ltd 2 variants

Ref FLI-20BModel FLI-20B, FLI-20E

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697636385ny024M Basic UDI-DI 06976363851020UDI-DIDate25 Feb 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
4K Endoscopic Fluorescent Imaging System
Model / Reference
FLI-20B, FLI-20E
Primary DI / UDI-DI
06976363851020
Basic UDI-DI
697636385ny024M
Direct Marketing DI
06976363851020
EMDN Code
Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000036076
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Nanjing Nuoyuan Medical Devices 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