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iTero Element™ 5D imaging system, Certified Pre-owned
EUDAMEDClass IIa (EU MDR)
Ref 217617Model iTero Element 5D Family
Identity
- Trade Name
- iTero Element™ 5D imaging system, Certified Pre-owned EUDAMED
- Device Name
- iTero Element 5D Family EUDAMED
- Model / Reference
- iTero Element 5D Family EUDAMED217617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063023012 EUDAMED
- Basic UDI-DI
- 081606302DISBH EUDAMED
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
Classification
- Device Class
- Class IIa 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™ 5D imaging system, Certified Pre-owned by Align Technology Ltd. — Class IIa — 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 | 081606302DISBH | Class IIa | 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 296006ce-4e74-4172-9d96-a523980012fa 61 fields · synced Jul 8, 2026