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Base BioCam, BioniQ, Screw-On
EUDAMEDClass IIb (EU MDR)
Ref 2207.00Model Base BioCam, BioniQ
by LASAK s.r.o.
Identity
- Trade Name
- Base BioCam, BioniQ, Screw-On EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Base BioCam, BioniQ EUDAMED2207.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573004385 EUDAMED
- Basic UDI-DI
- 85955730009Y2 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
Base BioCam, BioniQ, Screw-On 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 | 85955730009Y2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (1)
- EUDAMED e06407d7-22f9-4861-a733-02a982af1189 61 fields · synced Jul 25, 2026