Identity
- Trade Name
- Imaging Plate EUDAMEDFDA UDI
- Generic Name
- Digital imaging storage phosphor screen FDA UDI
- Device Name
- IMAGING PLATE #0 EUDAMEDIMAGING PLATE #1 - 4 PCS FDA UDI
- Model / Reference
- 5942594 EUDAMEDImaging Plate FDA UDI
- Description
- IMAGING PLATE #1 - 4 PCS FDA UDI
Identifiers
- Catalog Number
- 5942594 FDA UDI
- Primary DI / UDI-DI
- 40192155942590 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192155IMAGINGPLATEZP EUDAMED
- FDA Product Code
- EAM FDA UDI
- EMDN Code
- Z11060280 DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Digital imaging storage phosphor screen FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1960 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Imaging Plate 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 | 0192155IMAGINGPLATEZP | 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 00a26fd7-eb5a-4a21-9de2-c8e9a4350262 61 fields · synced Jul 10, 2026
- FDA UDI 21f5fbc5-d2ca-49a9-9cf8-d7e23af661dd 34 fields · synced May 29, 2026