← Back to catalogue
Invisalign Comprehensive Intervals
EUDAMEDClass IIa (EU MDR)
Ref 9052Model Invisalign System
Identity
- Trade Name
- Invisalign Comprehensive Intervals EUDAMED
- Device Name
- Invisalign System EUDAMED
- Model / Reference
- Invisalign System EUDAMED9052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063023883 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 Comprehensive 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Align Technology Inc.
- EUDAMED SRN
- US-MF-000000744
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (1)
- EUDAMED 2db9f867-a33b-4783-a6e8-0b1a6b1e623e 61 fields · synced Jul 10, 2026