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C-guide for guided surgery, H10 (GS)
EUDAMEDClass I (EU MDR)
Ref 2517.00Model 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
- C-guide for guided surgery, H10 (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 EUDAMED2517.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573002138 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
C-guide for guided surgery, H10 (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 38a3d49f-3501-42cf-b2c3-7fb3a06ad4db 61 fields · synced Jul 11, 2026