Scanbody, BioniQ, indexed – long
by LASAK s.r.o. EUDAMED
Active
Ref 2815.00Model Closed tray impression post; Pin extension for open tray impression components; Scanbody, BioniQ; ScanPost CEREC; Screw-On closed tray impression coping; Screw-On open tray impression coping; STANDARD impression coping
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number85955730007XW | Date17 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- BioniQ Impression and Laboratory Components
- Model / Reference
- Closed tray impression post, Pin extension for open tray impression components, Scanbody, BioniQ, ScanPost CEREC, Screw-On closed tray impression coping, Screw-On open tray impression coping, STANDARD impression coping, 2815.00
- Primary DI / UDI-DI
- 08595573001575
- Basic UDI-DI
- 85955730007XW
- EMDN Code
- Q010207 Dental impression devices for prosthetic dentistry
- Device Class
- Class I
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000031907
Other devices from LASAK s.r.o.
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