3D ACCESSORY KIT for CS 8x00 3D
by Carestream Dental LLC United States EUDAMED
Ref 5311196 EMDN Z12011280
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0192155EXTRAORALPPDSYSQQ | Date24 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- 3D Positioning Kit for 9X00
- Model / Reference
- 5311196
- Primary DI / UDI-DI
- 60192155951718
- Basic UDI-DI
- 0192155EXTRAORALPPDSYSQQ
- EMDN Code
- Z12011280 Patient positioning instruments - hardware accessories
- Device Class
- Class I
- Medical Purpose
- Extraoral positioning accessories are intended to be used by healthcare professionals for patient positioning during acquisition procedure for panoramic, 3D or when applicable cephalometric. Those equipment are at the direction of dental professionals as diagnostic support for pediatric and adult patients
Manufacturer details
- EUDAMED SRN
- US-PR-000057394
Other devices from Carestream Dental LLC
Properties & raw data
Show properties, registry sources and raw records
Other properties (1)
- Sterile: No
Sources (1)
- EUDAMED 60192155951718|0192155EXTRAORALPPDSYSQQ