Identity
- Trade Name
- CG799DEN EUDAMEDCG799 FDA UDI
- Generic Name
- Stationary intraoral dental x-ray system, digital FDA UDI
- Device Name
- CG798DEN EUDAMEDSIZE C COLLIMAT. FOR I/O XRAY UNITS FDA UDI
- Model / Reference
- 5154257 EUDAMEDCG799 FDA UDI
- Description
- SIZE C COLLIMAT. FOR I/O XRAY UNITS FDA UDI
Identifiers
- Catalog Number
- 5154257 FDA UDI
- Primary DI / UDI-DI
- 60192155154256 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192155RHFCOLLIMATORCD EUDAMED
- FDA Product Code
- EHD FDA UDI
- EMDN Code
- Z11030580 RADIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Stationary intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cg799den by Carestream Dental LLC — 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 | 0192155RHFCOLLIMATORCD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carestream Dental LLC
- EUDAMED SRN
- US-MF-000003727
- Authorised Representative
- TROPHY FR-AR-000001797
Sources (2)
- EUDAMED 4b9dfaab-809c-43fa-9582-34b4f2bf4d28 61 fields · synced Jul 17, 2026
- FDA UDI 1084b9ab-a4c1-4bc1-8f17-e5a34a93f258 35 fields · synced May 30, 2026