Identity
- Trade Name
- CS 8100 3D EUDAMEDFDA UDI
- Generic Name
- Stationary extraoral dental x-ray system, digital FDA UDI
- Device Name
- CS 8100 3D EUDAMEDFDA UDI
- Model / Reference
- 5500319 EUDAMEDCS 8100 3D FDA UDI
- Description
- CS 8100 3D FDA UDI
Identifiers
- Catalog Number
- 5500319 FDA UDI
- Primary DI / UDI-DI
- 60192155500312 EUDAMEDFDA UDI
- Basic UDI-DI
- 019215581003DS4 EUDAMED
- FDA Product Code
- OAS FDA UDIMUH FDA UDI
- EMDN Code
- Z11030302 EUDAMED
- GMDN Term
- Stationary extraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI872.1800 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
Cs 8100 3d by Carestream Dental LLC — Class IIb — 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 | 019215581003DS4 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 378c5aad-f320-4353-a8ae-0d17f60f8602 61 fields · synced Jul 8, 2026
- FDA UDI 0e76349e-75c6-4487-976b-b68ee26fbaad 34 fields · synced May 30, 2026