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iTero Lumina Scanning Unit RMA
EUDAMEDClass I (EU MDR)
Ref 216498Model iTero Lumina System
Identity
- Trade Name
- iTero Lumina Scanning Unit RMA EUDAMED
- Device Name
- iTero Lumina System EUDAMED
- Model / Reference
- iTero Lumina System EUDAMED216498 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022954 EUDAMED
- Basic UDI-DI
- 081606302LMNSYS9L 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 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 | 081606302LMNSYS9L | 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 (1)
- EUDAMED 0c484429-70e3-4836-98c6-66c1e10239ac 61 fields · synced Jun 19, 2026