Identity
- Trade Name
- SCAN CEPH EUDAMEDCS 8100SC FDA UDI
- Generic Name
- Stationary cephalometric x-ray system, digital FDA UDI
- Device Name
- SCAN CEPH EUDAMEDSC UPGRADE FOR CS 8100 FDA UDI
- Model / Reference
- 5314562 EUDAMEDCS 8100SC FDA UDI
- Description
- SC UPGRADE FOR CS 8100 FDA UDI
Identifiers
- Catalog Number
- 5314562 FDA UDI
- Primary DI / UDI-DI
- 60192155314568 EUDAMEDFDA UDI
- Basic UDI-DI
- 0192155SCANCEPHRR EUDAMED
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11030380 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Stationary cephalometric x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 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
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
Scan Ceph 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 | 0192155SCANCEPHRR | 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 382ac2a3-8ad8-4781-ab82-b4752b395acf 61 fields · synced Jul 12, 2026
- FDA UDI 076e2077-4eae-4440-88fe-e488c2db3dfd 34 fields · synced May 30, 2026