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iTero Element Scanner Sleeve
EUDAMEDClass IIa (EU MDR)
Ref 221963Model iTero Element Scanner Sleeves
Identity
- Trade Name
- iTero Element Scanner Sleeve EUDAMED
- Device Name
- iTero Element Scanner Sleeves EUDAMED
- Model / Reference
- iTero Element Scanner Sleeves EUDAMED221963 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022183 EUDAMED
- Basic UDI-DI
- 081606302SLEEVE6S EUDAMED
- EMDN Code
- Z12119085 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES 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 Scanner Sleeve 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 | 081606302SLEEVE6S | 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 287d21d4-aacb-4c05-984a-03e10e8d8d28 61 fields · synced Jun 18, 2026