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Guide wrench BioniQ
EUDAMEDClass I (EU MDR)
Ref 2410.00Model Guide wrench BioniQ
by LASAK s.r.o.
Identity
- Trade Name
- Guide wrench BioniQ EUDAMED
- Device Name
- BioniQ Instruments, Non-active non-implantable instruments EUDAMED
- Model / Reference
- Guide wrench BioniQ EUDAMED2410.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573002176 EUDAMED
- Basic UDI-DI
- 85955730046Y8 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
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
Guide wrench BioniQ 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 | 85955730046Y8 | Class I | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED 3542f89a-336f-47e9-b9e0-e4177c9b6c26 61 fields · synced Jun 19, 2026