← Back to catalogue
iTero Lumina Pro Scanning Unit, RMA Package
EUDAMEDClass IIa (EU MDR)
Ref 221956Model iTero Lumina Pro intraoral scanning unit
Identity
- Trade Name
- iTero Lumina Pro Scanning Unit, RMA Package EUDAMED
- Device Name
- iTero Lumina Pro intraoral scanning unit EUDAMED
- Model / Reference
- iTero Lumina Pro intraoral scanning unit EUDAMED221956 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022275 EUDAMED
- Basic UDI-DI
- 081606302IOCPRO5A EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa 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 Pro Scanning Unit, RMA Package by Align Technology Ltd. — Class IIa — 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 | 081606302IOCPRO5A | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Align Technology Ltd.
- EUDAMED SRN
- IL-MF-000000745
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (1)
- EUDAMED 8fb5d5da-d7e9-45ce-bb3a-4375db569188 61 fields · synced Jun 18, 2026