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BioniQ implant – straight
EUDAMEDClass IIb (EU MDR)
Ref 2009.16Model BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straight
by LASAK s.r.o.
Identity
- Trade Name
- BioniQ implant – straight EUDAMED
- Device Name
- BioniQ Dental Implants EUDAMED
- Model / Reference
- BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straight EUDAMED2009.16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573002800 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 – 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 d4451a36-cf61-428f-a848-35fa15c20054 61 fields · synced Jun 18, 2026