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iTero Lumina Scanning Unit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 214500Model iTero Lumina System
Identity
- Trade Name
- iTero Lumina Scanning Unit EUDAMEDFDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- iTero Lumina System EUDAMEDScanning unit (wand) FDA UDI
- Model / Reference
- iTero Lumina System EUDAMED214500 EUDAMEDFDA UDI
- Description
- Scanning unit (wand) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021599 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302LMNSYS9L EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iTero Lumina Scanning Unit by Align Technology Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081606302LMNSYS9L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 6c82f5e9-a2b6-4065-afd6-84ed049abadd 61 fields · synced Jul 10, 2026
- FDA UDI c21c9fba-3854-498e-92ff-87afe682e6a1 33 fields · synced May 30, 2026