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iTero Element 2 Plus
EUDAMEDClass I (EU MDR)
Ref 217105Model iTero Element 2 family
Identity
- Trade Name
- iTero Element 2 Plus EUDAMED
- Device Name
- iTero Element 2 family EUDAMED
- Model / Reference
- iTero Element 2 family EUDAMED217105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022534 EUDAMED
- Basic UDI-DI
- 081606302ELEMENT6L 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 Element 2 Plus 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 | 081606302ELEMENT6L | 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 2f1786b7-ea89-4d46-8fc4-d3d9aa27e39b 61 fields · synced May 21, 2026