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BioCam abutment, BioniQ, indexed
EUDAMEDClass IIb (EU MDR)
Ref 2181.00Model Ti base CEREC; BioCam abutment, BioniQ
by LASAK s.r.o.
Identity
- Trade Name
- BioCam abutment, BioniQ, indexed EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Ti base CEREC; BioCam abutment, BioniQ EUDAMED2181.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573006372 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 (1)
- EUDAMED 760a1142-24ef-47ef-a4da-f77da12616bd 61 fields · synced Jun 19, 2026