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Ikoniscope20 High Volume

by Ikonisys, Inc.

Ref Ikoniscope 20 160Model 20-160

Active European Union

CE IVDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0860007933523UA Basic UDI-DI 00860007933523UDI-DIDate21 Dec 2022RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
20-160, Ikoniscope 20 160
Primary DI / UDI-DI
00860007933523
Basic UDI-DI
0860007933523UA
Direct Marketing DI
00860007933523
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000031487
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Ikonisys, Inc.

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No