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iTero Element Flex
EUDAMEDClass I (EU MDR)
Ref 212094Model iTero Element 2 family
Identity
- Trade Name
- iTero Element Flex EUDAMED
- Device Name
- iTero Element 2 family EUDAMED
- Model / Reference
- iTero Element 2 family EUDAMED212094 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063020905 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 Flex 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 5cc927dc-baa8-42cb-be93-2d11eb781649 61 fields · synced Jun 17, 2026