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Fixing screw AN, BioniQ
EUDAMEDClass IIa (EU MDR)
Ref 2228.00Model Fixing screw, BioniQ; Fixing screw AN, BioniQ; PLS BioniQ – fixing screw
by LASAK s.r.o.
Identity
- Trade Name
- Fixing screw AN, BioniQ EUDAMED
- Device Name
- BioniQ Prosthetic components EUDAMED
- Model / Reference
- Fixing screw, BioniQ; Fixing screw AN, BioniQ; PLS BioniQ – fixing screw EUDAMED2228.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573022532 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 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 42ec5a81-3b84-40b6-9644-11b9abebd0b2 61 fields · synced Jun 18, 2026