S2
by Carestream Dental LLC 2 variants
Ref 5945241Model 6200
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 | Number0192155RVG9XP | Date13 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- Withdrawn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
- Device Name
- Rvg 62006200
- Model / Reference
- 5945241, 6200
- Primary DI / UDI-DI
- 60192155951060, 60192155951268
- Basic UDI-DI
- 0192155RVG9XP, 0192155RVG9SYSX2
- EMDN Code
- Z11030402 Systems for intraoral digital videoradiography
- Device Class
- Class IIa
- EU market of registration
- France
- Medical Purpose
- The RVG 142, RVG 5200, RVG 6200, RVG Optima and DENTRA lll digital intra-oral X-ray sensors are intended to produce an image of the dental area at the direction of dentists, oral surgeons and orthodontists for X-ray imaging of the dento-maxillofacial area 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