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Otoscope

by Jiangxi China Medical Equipment Co., Ltd 21 variants

Ref EJ-2Model 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

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 Number697604283SZ-EJPB Basic UDI-DI 06976042831411UDI-DIDate20 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  • Withdrawn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

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, EJ-2
Primary DI / UDI-DI
06976042831411
Basic UDI-DI
697604283SZ-EJPB
EMDN Code
Z12021007 Middle ear otoscopes
Device Class
Class I
EU 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

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