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Fixing screw, BioniQ
EUDAMEDClass IIa (EU MDR)
Ref 2191.00Model Fixing screw, BioniQ; Fixing screw AN, BioniQ; PLS BioniQ – fixing screw
by LASAK s.r.o.
Identity
- Trade Name
- Fixing screw, BioniQ EUDAMED
- Device Name
- BioniQ Prosthetic components EUDAMED
- Model / Reference
- Fixing screw, BioniQ; Fixing screw AN, BioniQ; PLS BioniQ – fixing screw EUDAMED2191.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573004552 EUDAMED
- Basic UDI-DI
- 85955730008XY EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
Fixing screw, BioniQ 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 | 85955730008XY | Class IIa | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED 5f5b62bf-8107-4470-8e46-4a72335cd508 61 fields · synced Jun 17, 2026