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Roundburr d1.8
EUDAMEDClass IIa (EU MDR)
Ref 2443.00Model Roundburr
by LASAK s.r.o.
Identity
- Trade Name
- Roundburr d1.8 EUDAMED
- Device Name
- BioniQ Instruments EUDAMED
- Model / Reference
- Roundburr EUDAMED2443.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573021191 EUDAMED
- Basic UDI-DI
- 85955730052Y3 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
Roundburr d1.8 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 | 85955730052Y3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED c5ce0249-e3f1-4746-820a-e50953b6415d 61 fields · synced Jun 18, 2026