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iTero Plus Computing unit
EUDAMEDClass I (EU MDR)
Ref 217592Model iTero Plus Series Platform, Accessories for iTero ScannersRef 212272
Identity
- Trade Name
- iTero Plus Computing unit EUDAMED
- Device Name
- iTero Plus Series Platform, Accessories for iTero Scanners EUDAMED
- Model / Reference
- iTero Plus Series Platform, Accessories for iTero Scanners EUDAMED217592 EUDAMED212272 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063021865 EUDAMED00816063021766 EUDAMED
- Basic UDI-DI
- 0081606302PlusMCU5U EUDAMED0081606302PlusCUKH 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 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 (2)
- EUDAMED 44e9218d-695a-45a9-ba8a-d42a62826e3c 61 fields · synced Jul 28, 2026
- EUDAMED 5ab84c51-6aad-4745-868b-984e0412dc2d 61 fields · synced May 18, 2026