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Invisalign System - Comprehensive
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9000Model Invisalign System
Identity
- Trade Name
- Invisalign System - Comprehensive EUDAMEDFDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- Invisalign System EUDAMEDSequential Aligners FDA UDI
- Model / Reference
- Invisalign System EUDAMED9000 EUDAMEDFDA UDI
- Description
- Sequential Aligners FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020189 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302InvisalignMH EUDAMED
- FDA Product Code
- NXC FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic progressive aligner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Invisalign System - Comprehensive by Align Technology, Inc. — Class IIa — 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 | 081606302InvisalignMH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Align Technology Inc.
- EUDAMED SRN
- US-MF-000000744
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (2)
- EUDAMED 751356a5-d9b2-4aa7-ad60-8e916fbf149d 61 fields · synced Jun 19, 2026
- FDA UDI 7a348f0f-1989-4d76-86ee-e19967c810c9 33 fields · synced May 30, 2026