Identity
- Trade Name
- Trophy 3D Imaging EUDAMEDFDA UDI
- Generic Name
- General-purpose dental x-ray system application software FDA UDI
- Device Name
- CS 3D Imaging EUDAMEDTROPHY 3D IMAGING FDA UDI
- Model / Reference
- 5319553 EUDAMEDTrophy 3D Imaging FDA UDI
- Description
- TROPHY 3D IMAGING FDA UDI
Identifiers
- Catalog Number
- 5319553 FDA UDI
- Primary DI / UDI-DI
- 60192155319556 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192155CS3DSS EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030392 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- General-purpose dental x-ray system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Trophy 3D Imaging by Carestream Dental LLC — 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 | 0192155CS3DSS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Carestream Dental LLC
- EUDAMED SRN
- US-MF-000003727
- Authorised Representative
- TROPHY FR-AR-000001797
Sources (2)
- EUDAMED 52a76fbe-12f3-437b-a8ba-2427bb0df1c1 61 fields · synced Jun 18, 2026
- FDA UDI 6d0495b1-be10-499c-a1ea-bfaf47c0d6fe 34 fields · synced May 30, 2026