Identity
- Trade Name
- CS 1500 FDA UDI
- Generic Name
- Flexible video stomatoscope FDA UDI
- Device Name
- CS 1500 EUDAMEDCS1500 INTRA ORAL CAMERA WIRED USB FDA UDI
- Model / Reference
- 6559819 EUDAMEDCS 1500 FDA UDI
- Description
- CS1500 INTRA ORAL CAMERA WIRED USB FDA UDI
Identifiers
- Catalog Number
- 6559819 FDA UDI
- Primary DI / UDI-DI
- 60192156559814 EUDAMEDFDA UDI
- Basic UDI-DI
- 01921551500W5Z EUDAMED
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Flexible video stomatoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental delivery system
Cs 1500 by Carestream Dental LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 01921551500W5Z | 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 a3606389-7df1-4aa2-a140-3c7b3a0a1502 61 fields · synced Jun 8, 2026
- FDA UDI b095e391-e187-409d-b40a-e949e2855a45 34 fields · synced May 29, 2026