Cs 2200
by Carestream Dental LLC 10 variants
Ref 5154323
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number01921552X00NL 60192155154324 | Date12 Oct 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 5154323
- Primary DI / UDI-DI
- 60192155154324
- Basic UDI-DI
- 01921552X00NL, 01921552X00SYS5U
- EMDN Code
- Z1103040102 Equipment for digital endoral radiology
- Device Class
- Class IIb
- EU market of registration
- France
- Medical Purpose
- CS 2100 and CS 2200 intraoral x-ray equipment are intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures, at the direction of dental professionals as diagnostic support for pediatric and adult patients.
Manufacturer details
- EUDAMED SRN
- US-MF-000003727
- Authorised representative
- TROPHY FR-AR-000001797
Other devices from Carestream Dental LLC
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No