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BioCam abutment, BioniQ, indexed
EUDAMEDClass IIb (EU MDR)
Ref 2181.20Model Ti base CEREC; BioCam abutment, BioniQRef 2189.20Ref 2186.00Ref 2186.20Ref 2159.20
by LASAK s.r.o.
Identity
- Trade Name
- BioCam abutment, BioniQ, indexed EUDAMEDBioCam abutment, BioniQ, non-indexed EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Ti base CEREC; BioCam abutment, BioniQ EUDAMED2181.20 EUDAMED2189.20 EUDAMED2186.00 EUDAMED2186.20 EUDAMED2159.20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573006389 EUDAMED08595573006327 EUDAMED08595573006297 EUDAMED08595573006303 EUDAMED08595573006365 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, indexed 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 (5)
- EUDAMED 314f8f38-9117-4b14-a435-6727749786e7 61 fields · synced Jul 30, 2026
- EUDAMED 114f5ccf-e30d-4663-be92-9e3231e92b3b 61 fields · synced May 17, 2026
- EUDAMED 8185f611-e916-4702-8643-7a4551fb4553 61 fields · synced May 17, 2026
- EUDAMED 2590914f-0156-4443-9cef-f819f4f99d9a 61 fields · synced May 18, 2026
- EUDAMED 496d54dd-ae70-4c6d-a9cd-bf25ddea27b9 61 fields · synced May 18, 2026