Identity
- Trade Name
- iTero Lumina PC cfg EUDAMED
- Device Name
- iTero Lumina – PC cfg EUDAMED
- Model / Reference
- 223101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063023234 EUDAMED
- Basic UDI-DI
- 081606302LMN22SYSEL EUDAMED
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- iTero Lumina PC cfg intraoral scanning unit: The iTero Lumina PC cfg intraoral scanning unit is intended to capture 3D and 2D color images of the patient’s oral cavity. The intraoral scanner is intended to record the topographical images of teeth, oral tissue and bite relationship and to obtain optical impressions for use in CAD/CAM of dental devices. iTero Lumina software: The data processing, displayed and stored by the iTero Lumina Software may be used by dental healthcare professionals for assessing intraoral topographical images of hard and soft tissue and visual assessments. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
iTero Lumina PC cfg by Align Technology Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081606302LMN22SYSEL | Class I | Active |
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Manufacturer
- Manufacturer
- Align Technology Ltd.
- EUDAMED SRN
- IL-PR-000047276
Sources (1)
- EUDAMED 04ae9d23-f949-423d-a45f-da4b93ab297d 61 fields · synced Jun 19, 2026