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BioCam abutment, BioniQ, bridge
EUDAMEDClass IIb (EU MDR)
Ref 2158.00Model Ti base CEREC; BioCam abutment, BioniQRef 2158.20
by LASAK s.r.o.
Identity
- Trade Name
- BioCam abutment, BioniQ, bridge EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Ti base CEREC; BioCam abutment, BioniQ EUDAMED2158.00 EUDAMED2158.20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573006334 EUDAMED08595573006341 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
BioCam abutment, BioniQ, bridge 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 eb409805-990f-4f17-906e-9c1dabd4a8ed 61 fields · synced Jul 31, 2026
- EUDAMED 58210b8b-e3fc-4519-b206-b68b2a6b4c0d 61 fields · synced May 19, 2026