Identity
- Trade Name
- CG798DEN EUDAMEDCG798 FDA UDI
- Generic Name
- Stationary intraoral dental x-ray system, digital FDA UDI
- Device Name
- CG798DEN EUDAMEDSIZE B COLLIMAT. FOR I/O XRAY UNITS FDA UDI
- Model / Reference
- 5154240 EUDAMEDCG798 FDA UDI
- Description
- SIZE B COLLIMAT. FOR I/O XRAY UNITS FDA UDI
Identifiers
- Catalog Number
- 5154240 FDA UDI
- Primary DI / UDI-DI
- 60192155154249 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
Cg798den 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 |
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Manufacturer
- Manufacturer
- Carestream Dental LLC
- EUDAMED SRN
- US-MF-000003727
- Authorised Representative
- TROPHY FR-AR-000001797
Sources (2)
- EUDAMED ac17c27f-c4ed-43f5-8b9c-ee00c670b1ce 61 fields · synced Jun 17, 2026
- FDA UDI 82e3fa92-87f4-4a3c-9413-262e5b1ab9d4 35 fields · synced May 29, 2026