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Uni-Base, BioniQ, indexed, narrow
EUDAMEDClass IIb (EU MDR)
Ref 2216.15Model Uni-Base, BioniQ; Uni-Base AN, BioniQRef 2208.25Ref 2216.25Ref 2208.15Ref 2208.07Ref 2216.35Ref 2208.35
by LASAK s.r.o.
Identity
- Trade Name
- Uni-Base, BioniQ, indexed, narrow EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Uni-Base, BioniQ; Uni-Base AN, BioniQ EUDAMED2216.15 EUDAMED2208.25 EUDAMED2216.25 EUDAMED2208.15 EUDAMED2208.07 EUDAMED2216.35 EUDAMED2208.35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573014742 EUDAMED08595573014711 EUDAMED08595573014759 EUDAMED08595573014704 EUDAMED08595573014698 EUDAMED08595573014766 EUDAMED08595573014728 EUDAMED
- Basic UDI-DI
- 85955730026Y2 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
Uni-Base, BioniQ, indexed, narrow 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 | 85955730026Y2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- LASAK s.r.o.
- EUDAMED SRN
- CZ-MF-000031907
Sources (7)
- EUDAMED 3bcd85ed-37b5-4f56-b6ac-1cb32f88ff14 61 fields · synced Sep 17, 2026
- EUDAMED 537d85bf-65c7-4027-953c-217052b4166c 61 fields · synced May 16, 2026
- EUDAMED 56932ec8-8187-427a-a179-1585f53d0027 61 fields · synced May 16, 2026
- EUDAMED ef368d22-6f9c-45dd-a8bd-186a233548a9 61 fields · synced May 18, 2026
- EUDAMED f574ec9d-52ac-4a0d-a19c-99ab80a1b059 61 fields · synced May 18, 2026
- EUDAMED 1b85ff13-c7d5-4020-95fa-9c93fed5c261 61 fields · synced May 18, 2026
- EUDAMED 6953791d-8398-4a32-bfe1-9e98bde7ffa6 61 fields · synced May 18, 2026