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BioniQ implant – tapered
EUDAMEDClass IIb (EU MDR)
Ref 2020.16Model BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straightRef 2012.12Ref 2012.10Ref 2020.14Ref 2020.08Ref 2012.08Ref 2020.10
by LASAK s.r.o.
Identity
- Trade Name
- BioniQ implant – tapered EUDAMED
- Device Name
- BioniQ Dental Implants EUDAMED
- Model / Reference
- BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straight EUDAMED2020.16 EUDAMED2012.12 EUDAMED2012.10 EUDAMED2020.14 EUDAMED2020.08 EUDAMED2012.08 EUDAMED2020.10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573003142 EUDAMED08595573002886 EUDAMED08595573002879 EUDAMED08595573003135 EUDAMED08595573003104 EUDAMED08595573002862 EUDAMED08595573003111 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 – tapered 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 (7)
- EUDAMED 40d65372-7490-4957-aed7-b9edaf9a21e6 61 fields · synced Aug 1, 2026
- EUDAMED fe8f1894-e12c-43fa-835b-0f2b62a611ed 61 fields · synced May 16, 2026
- EUDAMED defdd190-854a-4e86-9be7-a0cc18d0f5b4 61 fields · synced May 16, 2026
- EUDAMED 844b23be-2b3f-4204-96f7-b5ca414a4cab 61 fields · synced May 17, 2026
- EUDAMED 4b7554d7-7e0b-4b8c-868a-f10ad3f57524 61 fields · synced May 18, 2026
- EUDAMED f3546dbd-ba0c-4e22-b191-b0c9f151f92e 61 fields · synced May 18, 2026
- EUDAMED ae9b2f63-550d-4216-b3b1-4d44313e52cc 61 fields · synced May 19, 2026