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BioniQ implant Plus – straight
EUDAMEDClass IIb (EU MDR)
Ref 2026.12Model BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straight
by LASAK s.r.o.
Identity
- Trade Name
- BioniQ implant Plus – straight EUDAMED
- Device Name
- BioniQ Dental Implants EUDAMED
- Model / Reference
- BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straight EUDAMED2026.12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573003203 EUDAMED
- Basic UDI-DI
- 85955730001XJ EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
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
BioniQ implant Plus – straight by LASAK s.r.o. — Class IIb — 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 | 85955730001XJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED e883024f-09bf-4f14-81ee-d4a4a5fd2748 61 fields · synced Jun 18, 2026