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Drill guide for guided drill S3.5 (GS)
EUDAMEDClass I (EU MDR)
Ref 2514.00Model C-guide for guided surgery; Drill guide for guided drill; Drill stop for drills; Guided fixation pin; Implant carrier remover; Screw remover set; Screw remover set BioniQ; Screwdriver; Screw-On abutment holder
by LASAK s.r.o.
Identity
- Trade Name
- Drill guide for guided drill S3.5 (GS) EUDAMED
- Device Name
- BioniQ Instruments EUDAMED
- Model / Reference
- C-guide for guided surgery; Drill guide for guided drill; Drill stop for drills; Guided fixation pin; Implant carrier remover; Screw remover set; Screw remover set BioniQ; Screwdriver; Screw-On abutment holder EUDAMED2514.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573002206 EUDAMED
- Basic UDI-DI
- 85955730002XL EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Drill guide for guided drill S3.5 (GS) by LASAK s.r.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85955730002XL | Class I | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED feb8c975-d5ff-4236-af08-729afec6888b 61 fields · synced Jun 19, 2026