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iTero Lumina PC cfg Scanning Unit, RMA Package
EUDAMEDClass I (EU MDR)
Ref 223126Ref 223125
Identity
- Trade Name
- iTero Lumina PC cfg Scanning Unit, RMA Package EUDAMED
- Device Name
- iTero Lumina PC cfg Intraoral Scanning Unit EUDAMED
- Model / Reference
- 223126 EUDAMED223125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063023272 EUDAMED00816063023265 EUDAMED
- Basic UDI-DI
- 081606302LMNSCNUEV EUDAMED
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 Package 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 ce4b27a7-10c5-4843-81e7-85628a49cd73 61 fields · synced Jul 18, 2026
- EUDAMED cbc1451a-93d0-4f8b-824a-e9223cc9fbf1 61 fields · synced May 18, 2026