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Invisalign Impression Tray, Plastic, Upper, Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2564Model Invisalign Impression Tray
Identity
- Trade Name
- Invisalign Impression Tray, Plastic, Upper, Large EUDAMEDInvisalign Impression Tray Large Upper FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Invisalign Impression Tray EUDAMEDLarge PVS Upper Tray FDA UDI
- Model / Reference
- Invisalign Impression Tray EUDAMED2564 EUDAMEDFDA UDI
- Description
- Large PVS Upper Tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020363 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302ImpTrayCC EUDAMED
- FDA Product Code
- EHY FDA UDI
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6880 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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 Impression Tray, Plastic, Upper, Large by Align Technology, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 081606302ImpTrayCC | 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 59ad3b34-f878-4bdb-81f2-2ec237a96ae2 61 fields · synced Jul 15, 2026
- FDA UDI a8bdac44-d216-493c-9915-06ed4f89b96b 33 fields · synced May 30, 2026