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Automatic Non-mydriatic Fundus Camera

by Hangzhou AI-MU Meditec Co., Ltd.

Ref iFLASH-I SMART, iFLASH-I PLUS

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 linked in EUDAMED

A group certificate may exist

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/MDR Number697635971iFLASH8B Basic UDI-DI Date26 Jun 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Automatic Non-mydriatic Fundus Camera
Model / Reference
iFLASH-I SMART, iFLASH-I PLUS
Primary DI / UDI-DI
06976359710010, 06976359710027
Basic UDI-DI
697635971iFLASH8B, 697635971iPLUS83
Direct Marketing DI
06976359710010
06976359710027
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000036109
Authorised representative
Everbiz GmbH AT-AR-000035279

Other devices from Hangzhou AI-MU Meditec Co., Ltd.

Properties

  • Reusable NoEUDAMEDYesEUDAMED

Other properties (12)

  • Sterile: No
  • Implantable: 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