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Invisalign Specifix Attachment System with Engagement Features:
EUDAMEDClass IIa (EU MDR)
Ref 5035
Identity
- Trade Name
- Invisalign Specifix Attachment System with Engagement Features: EUDAMED
- Device Name
- Invisalign Specifix Attachment System EUDAMED
- Model / Reference
- 5035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063023784 EUDAMED
- Basic UDI-DI
- 081606302Specifix8W 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 Specifix Attachment System with Engagement Features: 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 | 081606302Specifix8W | 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 3a70c924-a1ac-4c48-b53c-7ce3491a7def 61 fields · synced Aug 2, 2026