Guide Pin for Bone Profiler
by LASAK s.r.o. EUDAMED
Active
Ref 2547.00Model C-guide for guided surgery; Drill guide for guided drill; Drill stop for drills; Guide Pin for Bone Profiler; Guided fixation pin;Implant carrier remover; Screw remover set; Screw remover set BioniQ; Screwdriver; Screw-On abutment holder
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number85955730002XL | Date17 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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 Instruments
- Model / Reference
- C-guide for guided surgery, Drill guide for guided drill, Drill stop for drills, Guide Pin for Bone Profiler, Guided fixation pin, Implant carrier remover, Screw remover set, Screw remover set BioniQ, Screwdriver, Screw-On abutment holder, 2547.00
- Primary DI / UDI-DI
- 08595573023331
- Basic UDI-DI
- 85955730002XL
- EMDN Code
- L159099 Odontostomatology instruments, reusable - other
- 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