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Invisalign Cleaning System for Aligners and Retainers (with Tub)
EUDAMEDClass I (EU MDR)
Ref 76008Model Invisalign Cleaning Crystals
Identity
- Trade Name
- Invisalign Cleaning System for Aligners and Retainers (with Tub) EUDAMED
- Device Name
- Invisalign Cleaning Crystals EUDAMED
- Model / Reference
- Invisalign Cleaning Crystals EUDAMED76008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816063021179 EUDAMED
- Basic UDI-DI
- 081606302CCrystalsRM EUDAMED
- EMDN Code
- V0799 PRODUCTS FOR CLEANING MEDICAL 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 Cleaning System for Aligners and Retainers (with Tub) 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 | 081606302CCrystalsRM | 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 3b694986-b1d6-4dff-ab9e-a0f001cac951 61 fields · synced Jul 21, 2026