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PLS BioniQ – fixing screw, slot
EUDAMEDClass IIa (EU MDR)
Ref 2161.30Model Fixing screw, BioniQ; Fixing screw AN, BioniQ; PLS BioniQ – fixing screw
by LASAK s.r.o.
Identity
- Trade Name
- PLS BioniQ – fixing screw, slot EUDAMED
- Device Name
- BioniQ Prosthetic components EUDAMED
- Model / Reference
- Fixing screw, BioniQ; Fixing screw AN, BioniQ; PLS BioniQ – fixing screw EUDAMED2161.30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573012458 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
PLS BioniQ – fixing screw, slot 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 231547f3-2556-42ba-a96b-b9f31c2720a7 61 fields · synced Aug 3, 2026