iTero Lumina Pro Mobile

by Align Technology Ltd. 2 variants

Ref 221908

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number081606302LMNPRO88 Basic UDI-DI 00816063022862UDI-DI	Date15 May 2025Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: iTero Lumina™ Pro / iTero Lumina™ Pro Mobile
Model / Reference: 221908

Primary DI / UDI-DI: 00816063022862
Basic UDI-DI: 081606302LMNPRO88
EMDN Code: Q010207 Dental impression devices for prosthetic dentistry

Device Class: Class IIa
Medical Purpose: iTero Lumina Pro is dental imaging system intended to record and display the topographical images of teeth, oral tissue and bite relationship and to obtain optical impressions for use in CAD/CAM of dental devices. The system is also intended to record and display near infrared images of the teeth to aid in detecting interproximal caries above the gingiva and monitoring the progress of such lesions.

Manufacturer details

EUDAMED SRN: IL-PR-000047276

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Properties

Other properties (1)

Sterile: No