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Digital Intraoral Camera

by Zhuhai Aicreate Medical Technology Co., Ltd

Ref A9WModel A3M，A3M-X，A3S，A3S-X，A3W，A3W-X， A6M, A6M-X, A6S，A6S-X，A6W-X，A6W， A9M，A9M-X，A9S，A9S-X，A9W， A9W-X

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 Number697498747DIC001RE Basic UDI-DI 06974987470016UDI-DIDate31 Aug 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  • Withdrawn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
Digital Intraoral Camera
Model / Reference
A3M，A3M-X，A3S，A3S-X，A3W，A3W-X， A6M, A6M-X, A6S，A6S-X，A6W-X，A6W， A9M，A9M-X，A9S，A9S-X，A9W， A9W-X, A9W
Primary DI / UDI-DI
06974987470016
Basic UDI-DI
697498747DIC001RE
EMDN Code
Z119003 Bioimaging photography instruments
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000058237
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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