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Fixing screw AN, BioniQ – high
EUDAMEDClass IIa (EU MDR)
Ref 2254.00Model Fixing screw, BioniQ; Fixing screw AN, BioniQ; PLS BioniQ – fixing screwRef 2252.00Ref 2229.00
by LASAK s.r.o.
Identity
- Trade Name
- Fixing screw AN, BioniQ – high EUDAMEDFixing screw AN, BioniQ EUDAMED
- Device Name
- BioniQ Prosthetic components EUDAMED
- Model / Reference
- Fixing screw, BioniQ; Fixing screw AN, BioniQ; PLS BioniQ – fixing screw EUDAMED2254.00 EUDAMED2252.00 EUDAMED2229.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573022884 EUDAMED08595573022877 EUDAMED08595573022549 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 AN, BioniQ – high 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 (3)
- EUDAMED 76499960-9063-4a4e-b721-fdd55a0ea856 61 fields · synced Jul 31, 2026
- EUDAMED e3b87d47-f948-4b6e-aaac-b9f14cc220ef 61 fields · synced May 18, 2026
- EUDAMED bef797a3-42ea-44a4-b3af-d925a8d7f3d7 61 fields · synced May 19, 2026