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Invisalign Cheek Retractor, Medium
EUDAMEDFDA UDIClass I (EU MDR)
Ref 202430Model Invisalign Cheek Retractor, Medium
Identity
- Trade Name
- Invisalign Cheek Retractor, Medium EUDAMEDFDA UDI
- Generic Name
- Dental cheek retractor, home-use FDA UDI
- Device Name
- Invisalign Cheek Retractor, Medium EUDAMEDCheek Retractor FDA UDI
- Model / Reference
- Invisalign Cheek Retractor, Medium EUDAMED202430 EUDAMEDFDA UDI
- Description
- Cheek Retractor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021131 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302CheekRetR8 EUDAMED
- FDA Product Code
- EIG FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Dental cheek retractor, home-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Invisalign Cheek Retractor, Medium by Align Technology, Inc. — Class I — 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 | 081606302CheekRetR8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 7bc827a3-7794-42ac-931f-c4ea5ea44ced 61 fields · synced Jun 18, 2026
- FDA UDI d5624ec0-93f5-4d8f-a1cd-5e946aceb3e8 33 fields · synced May 30, 2026