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Uni-Base AN, BioniQ, bridge, wide
EUDAMEDClass IIb (EU MDR)
Ref 2226.25Model Uni-Base, BioniQ; Uni-Base AN, BioniQRef 2234.35Ref 2234.25Ref 2221.07Ref 2226.15Ref 2234.07Ref 2221.35Ref 2226.07
by LASAK s.r.o.
Identity
- Trade Name
- Uni-Base AN, BioniQ, bridge, wide EUDAMEDUni-Base, BioniQ, bridge, wide EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Uni-Base, BioniQ; Uni-Base AN, BioniQ EUDAMED2226.25 EUDAMED2234.35 EUDAMED2234.25 EUDAMED2221.07 EUDAMED2226.15 EUDAMED2234.07 EUDAMED2221.35 EUDAMED2226.07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573022686 EUDAMED08595573014520 EUDAMED08595573014513 EUDAMED08595573014452 EUDAMED08595573022679 EUDAMED08595573014490 EUDAMED08595573014483 EUDAMED08595573022662 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 AN, BioniQ, bridge, wide 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 (8)
- EUDAMED cca8c79a-8760-4de2-9d0e-bdb6456f39ba 61 fields · synced Jul 29, 2026
- EUDAMED b979b184-5118-4b8c-8d50-2e79953b0676 61 fields · synced May 17, 2026
- EUDAMED 4076e950-bfc7-4442-b5f1-f0e192dad4de 61 fields · synced May 17, 2026
- EUDAMED a73796bd-0add-46d6-b36d-e899a36663fe 61 fields · synced May 17, 2026
- EUDAMED d1f25260-b82f-4606-be5e-924579634b9a 61 fields · synced May 17, 2026
- EUDAMED 4871794c-8be1-474c-8d99-a2c5a80dfc40 61 fields · synced May 17, 2026
- EUDAMED eefc7e97-90bc-440e-8bbe-72810a216137 61 fields · synced May 17, 2026
- EUDAMED c47bfab3-96ff-49bc-8aaa-f4fc09e9353c 61 fields · synced May 18, 2026