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Uni-Base, BioniQ, non-indexed, narrow
EUDAMEDClass IIb (EU MDR)
Ref 2209.15Model Uni-Base, BioniQ; Uni-Base AN, BioniQRef 2217.07Ref 2217.15Ref 2209.35Ref 2209.07Ref 2217.25Ref 2217.35
by LASAK s.r.o.
Identity
- Trade Name
- Uni-Base, BioniQ, non-indexed, narrow EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Uni-Base, BioniQ; Uni-Base AN, BioniQ EUDAMED2209.15 EUDAMED2217.07 EUDAMED2217.15 EUDAMED2209.35 EUDAMED2209.07 EUDAMED2217.25 EUDAMED2217.35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573014384 EUDAMED08595573014414 EUDAMED08595573014421 EUDAMED08595573014407 EUDAMED08595573014377 EUDAMED08595573014438 EUDAMED08595573014445 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, non-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 81cd9918-2df0-4722-ac28-b21b5d00d6f5 61 fields · synced Jul 30, 2026
- EUDAMED 47d1d735-77dc-4c34-81c6-a2b629f53902 61 fields · synced May 17, 2026
- EUDAMED 12926a14-5c37-4828-a78c-ef7bdab7de39 61 fields · synced May 17, 2026
- EUDAMED 56aeadaf-4bce-408e-a5dc-6bc554600fee 61 fields · synced May 18, 2026
- EUDAMED f3b6d603-c7db-4846-bae5-5b902b5217cc 61 fields · synced May 18, 2026
- EUDAMED 48146ae7-2c59-4a46-b26f-77fae7468268 61 fields · synced May 18, 2026
- EUDAMED 450e3e4c-df05-4cc3-8c1b-65a102571318 61 fields · synced May 19, 2026