Identity
- Trade Name
- iTero Lumina Interface Box EUDAMED
- Device Name
- iTero Lumina Interface Box EUDAMED
- Model / Reference
- 223060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063023166 EUDAMED
- Basic UDI-DI
- 081606302LMNIFB57 EUDAMED
- EMDN Code
- Z12119085 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES 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 Interface Box 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 | 081606302LMNIFB57 | 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 b1c6f53c-0831-4e58-8ceb-9af2b16c5b5f 61 fields · synced Jul 16, 2026