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Premill abutment, BioniQ, AG – Ti
EUDAMEDClass IIb (EU MDR)
Ref 2196.00Model Premill abutment, BioniQ, AG – Ti; Premill abutment, BioniQ, NT – Ti; Massive abutment, BioniQRef 2197.00
by LASAK s.r.o.
Identity
- Trade Name
- Premill abutment, BioniQ, AG – Ti EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Premill abutment, BioniQ, AG – Ti; Premill abutment, BioniQ, NT – Ti; Massive abutment, BioniQ EUDAMED2196.00 EUDAMED2197.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573021863 EUDAMED08595573021870 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
Premill abutment, BioniQ, AG – Ti 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 (2)
- EUDAMED b1b31b0c-7fc2-4080-ba32-8e00b96c4b01 61 fields · synced Jul 27, 2026
- EUDAMED 2ed2b92c-adc9-4fe5-aeb2-5c53d8959119 61 fields · synced May 18, 2026