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iTero Lumina Scanner Sleeve
EUDAMEDFDA UDIClass I (EU MDR)
Ref 215470Model iTero Lumina Scanner Sleeve
Identity
- Trade Name
- iTero Lumina Scanner Sleeve EUDAMEDiTero Lumina 25 Disposable Sleeves Box FDA UDI
- Generic Name
- Optical medical device procedural cover FDA UDI
- Device Name
- iTero Lumina Scanner Sleeve EUDAMEDDisposable single use sleeves box FDA UDI
- Model / Reference
- iTero Lumina Scanner Sleeve EUDAMED215470 EUDAMEDFDA UDI
- Description
- Disposable single use sleeves box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021483 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302LMNSLV8K EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z12119085 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Optical medical device procedural cover FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
iTero Lumina Scanner Sleeve by Align Technology Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081606302LMNSLV8K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 4e0b410d-70a1-4be6-a5a5-2c5aa8b81dd4 61 fields · synced Jul 10, 2026
- FDA UDI 52e4cfb4-9bd9-4200-97fd-ff41a1a0f511 33 fields · synced May 30, 2026