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Trephine
EUDAMEDClass IIa (EU MDR)
Ref 5214.3Model Trephine; Trephine for guided surgeryRef 2521.00
by LASAK s.r.o.
Identity
- Trade Name
- Trephine EUDAMEDTrephine for guided surgery – d3.35 (GS) EUDAMED
- Device Name
- BioniQ Instruments EUDAMED
- Model / Reference
- Trephine; Trephine for guided surgery EUDAMED5214.3 EUDAMED2521.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573020590 EUDAMED08595573020606 EUDAMED
- Basic UDI-DI
- 85955730003XN EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Trephine by LASAK s.r.o. — Class IIa — 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 | 85955730003XN | Class IIa | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (2)
- EUDAMED 62cf338d-717e-4684-ba17-0c21a021d272 61 fields · synced Jul 28, 2026
- EUDAMED b17fe72e-9566-43a5-a464-df5970acd960 61 fields · synced May 18, 2026