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Ti base CEREC
EUDAMEDClass IIb (EU MDR)
Ref 2198.00Model Ti base CEREC; BioCam abutment, BioniQRef 2183.00
by LASAK s.r.o.
Identity
- Trade Name
- Ti base CEREC EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Ti base CEREC; BioCam abutment, BioniQ EUDAMED2198.00 EUDAMED2183.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573004415 EUDAMED08595573004408 EUDAMED
- Basic UDI-DI
- 85955730018Y3 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
Ti base CEREC 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 | 85955730018Y3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (2)
- EUDAMED 144b62fd-feb7-4944-9d15-bd9de1c5325b 61 fields · synced Jul 9, 2026
- EUDAMED 32f07a79-c2a5-403e-b69c-70fbae564f71 61 fields · synced May 19, 2026