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Massive abutment, BioniQ
EUDAMEDClass IIb (EU MDR)
Ref 2165.00Model Premill abutment, BioniQ, AG – Ti; Premill abutment, BioniQ, NT – Ti; Massive abutment, BioniQ
by LASAK s.r.o.
Identity
- Trade Name
- Massive abutment, BioniQ EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Premill abutment, BioniQ, AG – Ti; Premill abutment, BioniQ, NT – Ti; Massive abutment, BioniQ EUDAMED2165.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573009908 EUDAMED
- Basic UDI-DI
- 85955730028Y6 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
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
Massive abutment, BioniQ 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 | 85955730028Y6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED e765b769-3711-4350-a110-a5f330125a6d 61 fields · synced Jun 18, 2026