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Direct Ophthalmoscope

by Suzhou Kangjie Medical Inc. 3 variants

Ref Direct OphthalmoscopeModel KJ8A1

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697466603KJ8A1KY Basic UDI-DI 06974666030111UDI-DIDate9 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Direct Ophthalmoscope
Model / Reference
KJ8A1, Direct Ophthalmoscope
Primary DI / UDI-DI
06974666030111
Basic UDI-DI
697466603KJ8A1KY
Direct Marketing DI
06974666030111
EMDN Code
Z12120114 Ophthalmoscopes
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000008792
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Suzhou Kangjie Medical, Inc.

See all devices from Suzhou Kangjie Medical, Inc. →

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