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Invisalign lens (Sm EU Core)
EUDAMEDClass I (EU MDR)
Ref 223595Model Invisalign Lens
Identity
- Trade Name
- Invisalign lens (Sm EU Core) EUDAMED
- Device Name
- Invisalign Lens EUDAMED
- Model / Reference
- Invisalign Lens EUDAMED223595 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022787 EUDAMED
- Basic UDI-DI
- 081606302InvisalignLensGZ EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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
Category: Device sterilization/disinfection container, reusable
Invisalign lens (Sm EU Core) by Align Technology, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 081606302InvisalignLensGZ | Class I | Active |
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Manufacturer
- Manufacturer
- Align Technology Inc.
- EUDAMED SRN
- US-MF-000000744
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (1)
- EUDAMED 20924d4e-b684-406d-bd02-84761b78fa3c 61 fields · synced Jun 18, 2026