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Electronic Nasopharyngeal Endoscope

by Shenzhen Insighters Medical Technology Co., Ltd. United States EUDAMED

Ref iS-ENF42Model iS-ENF22, iS-ENC32, iS-ENC42, iS-ENF32, iS-ENF42

EMDN R010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697083172ENZK Basic UDI-DIDate12 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
iS-ENF22, iS-ENC32, iS-ENC42, iS-ENF32, iS-ENF42
Primary DI / UDI-DI
06977800302020
Basic UDI-DI
697083172ENZK
Direct Marketing DI
06977800302020
EMDN Code
R010101 Nasopharyngeal tubes
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000032018
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Nasopharyngeal airway, single-use

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 8b6bcf21-c668-4557-bce3-1d5525e19e90 61 fields · synced 22 Oct 2026