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Invisalign lens (Std EU Core)
EUDAMEDClass I (EU MDR)
Ref 223594Model Invisalign Lens
Identity
- Trade Name
- Invisalign lens (Std EU Core) EUDAMED
- Device Name
- Invisalign Lens EUDAMED
- Model / Reference
- Invisalign Lens EUDAMED223594 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063022749 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
Invisalign lens (Std EU Core) by Align Technology, Inc. — 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 | 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 454ad073-d895-4361-a195-2073ed82d898 61 fields · synced Jun 18, 2026