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iTero Element Flex
EUDAMEDClass I (EU MDR)
Ref 217106Model iTero Element 2 familyRef 212074Ref 218530
Identity
- Trade Name
- iTero Element Flex EUDAMEDiTero Element Flex CPO EUDAMED
- Device Name
- iTero Element 2 family EUDAMED
- Model / Reference
- iTero Element 2 family EUDAMED217106 EUDAMED212074 EUDAMED218530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022527 EUDAMED00816063021124 EUDAMED00816063022497 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 (3)
- EUDAMED 2be53d44-3c22-40dd-add8-44c1a98e58ca 61 fields · synced Aug 2, 2026
- EUDAMED 2cb4e2b5-8bb1-4adb-b105-1ad4198f2798 61 fields · synced May 18, 2026
- EUDAMED 8c5e6251-35fc-4cbe-b7ef-1c7623e26ef0 61 fields · synced May 19, 2026