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Insertion wrench BioniQ – long
EUDAMEDClass I (EU MDR)
Ref 2403.00Model Insertion wrench BioniQ for guided surgery; Insertion wrench
by LASAK s.r.o.
Identity
- Trade Name
- Insertion wrench BioniQ – long EUDAMED
- Device Name
- BioniQ Instruments, Non-active non-implantable instruments EUDAMED
- Model / Reference
- Insertion wrench BioniQ for guided surgery; Insertion wrench EUDAMED2403.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573002251 EUDAMED
- Basic UDI-DI
- 85955730047YA 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
Insertion wrench BioniQ – long 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 | 85955730047YA | Class I | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED 152d72d6-374f-44bd-8e51-482187193720 61 fields · synced Jul 9, 2026