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Invisalign Virtual Care

by Align Technology Inc.

Ref A040648

Active European Union

CE MDR

Valid until

28 Oct 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification B.V.

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 Number0081606302A040648VC68 Basic UDI-DI 00816063023319UDI-DIDate14 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3831212CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    2 Jul 2026
    Expires
    28 Oct 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Virtual Care
Model / Reference
A040648
Primary DI / UDI-DI
00816063023319
Basic UDI-DI
0081606302A040648VC68
Direct Marketing DI
00816063023319
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000000744
Authorised representative
Align Technology B.V. NL-AR-000000061

Other devices from Align Technology, Inc.

See all devices from Align Technology, 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