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iTero Plus Mobile Computing unit
EUDAMEDClass I (EU MDR)
Ref 212275Model iTero Plus Series Platform, Accessories for iTero Scanners
Identity
- Trade Name
- iTero Plus Mobile Computing unit EUDAMED
- Device Name
- iTero Plus Series Platform, Accessories for iTero Scanners EUDAMED
- Model / Reference
- iTero Plus Series Platform, Accessories for iTero Scanners EUDAMED212275 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063021773 EUDAMED
- Basic UDI-DI
- 0081606302PlusMCU5U EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES 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 Plus Mobile Computing unit 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 | 0081606302PlusMCU5U | 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 687030b4-f186-4a24-b644-6900ba071b1b 61 fields · synced Jun 19, 2026