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Otoscope

by Jiangxi China Medical Equipment Co., Ltd China EUDAMED

Ref 80010.211Model EJ-1、EH-2、EJ-3、EJ-4、80010.406、80010.409、80013.409、80017.409、80010.411、80013.411、80017.411、80010.309、80013.309、80010.311、80010.209、80013.209、80017.209、80010.211、80013.211、80017.211、80010.508T

EMDN Z12021007

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697604283SZ-EJPB Basic UDI-DIDate20 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
EJ-1、EH-2、EJ-3、EJ-4、80010.406、80010.409、80013.409、80017.409、80010.411、80013.411、80017.411、80010.309、80013.309、80010.311、80010.209、80013.209、80017.209、80010.211、80013.211、80017.211、80010.508T, 80010.211
Primary DI / UDI-DI
06976042831572
Basic UDI-DI
697604283SZ-EJPB
EMDN Code
Z12021007 Middle ear otoscopes
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000037457
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Otoscope, endoscopic

Other devices from Jiangxi China Medical Equipment Co., Ltd

See all devices from Jiangxi China Medical Equipment Co., Ltd →

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 e193127e-6541-4af6-b5c3-bb321d3403c8 61 fields · synced 24 Oct 2026