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Invisalign First Intervals
EUDAMEDClass IIa (EU MDR)
Ref 9051Model Invisalign System
Identity
- Trade Name
- Invisalign First Intervals EUDAMED
- Device Name
- Invisalign System EUDAMED
- Model / Reference
- Invisalign System EUDAMED9051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063023876 EUDAMED
- Basic UDI-DI
- 081606302InvisalignMH EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER 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
Invisalign First Intervals by Align Technology, Inc. — 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 | 081606302InvisalignMH | Class IIa | 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 6f09369d-7ad9-4511-a702-4f06894f67fc 61 fields · synced Jun 18, 2026