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iTero Lumina PC cfg Scanning Unit, RMA
EUDAMEDClass I (EU MDR)
Ref 223115Ref 223100
Identity
- Trade Name
- iTero Lumina PC cfg Scanning Unit, RMA EUDAMEDiTero Lumina PC cfg EUDAMED
- Device Name
- iTero Lumina PC cfg Intraoral Scanning Unit EUDAMEDiTero Lumina – PC cfg EUDAMED
- Model / Reference
- 223115 EUDAMED223100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063023302 EUDAMED00816063023203 EUDAMED
- Basic UDI-DI
- 081606302LMNSCNUEV EUDAMED081606302LMN22SYSEL EUDAMED
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iTero Lumina PC cfg Scanning Unit, RMA 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 | 081606302LMNSCNUEV | Class I | Active |
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Manufacturer
- Manufacturer
- Align Technology Ltd.
- EUDAMED SRN
- IL-MF-000000745
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (2)
- EUDAMED bb1138b5-ca27-4306-bc42-336df653c977 61 fields · synced Jul 11, 2026
- EUDAMED bd02406f-7b9f-4250-9ff6-f2efa273fd7f 61 fields · synced May 18, 2026