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Uni-Base, BioniQ, indexed, wide
EUDAMEDClass IIb (EU MDR)
Ref 2210.35Model Uni-Base, BioniQ; Uni-Base AN, BioniQRef 2230.15Ref 2230.35Ref 2218.15Ref 2210.15Ref 2230.25Ref 2225.35Ref 2225.15Ref 2225.25Ref 2218.35Ref 2210.25
by LASAK s.r.o.
Identity
- Trade Name
- Uni-Base, BioniQ, indexed, wide EUDAMED
- Device Name
- BioniQ Prosthetic Components EUDAMED
- Model / Reference
- Uni-Base, BioniQ; Uni-Base AN, BioniQ EUDAMED2210.35 EUDAMED2230.15 EUDAMED2230.35 EUDAMED2218.15 EUDAMED2210.15 EUDAMED2230.25 EUDAMED2225.35 EUDAMED2225.15 EUDAMED2225.25 EUDAMED2218.35 EUDAMED2210.25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595573014568 EUDAMED08595573014667 EUDAMED08595573014681 EUDAMED08595573014582 EUDAMED08595573014544 EUDAMED08595573014674 EUDAMED08595573014643 EUDAMED08595573014629 EUDAMED08595573014636 EUDAMED08595573014605 EUDAMED08595573014551 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, 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 (11)
- EUDAMED 4b2ff057-727f-4606-b636-c451bd955df5 61 fields · synced Aug 4, 2026
- EUDAMED ad30fbb0-5299-461a-bb64-8345b4f79445 61 fields · synced May 11, 2026
- EUDAMED 19d3e940-3b88-49e4-ac37-acc30c789612 61 fields · synced May 11, 2026
- EUDAMED 9e51692f-cc1d-4302-a75e-6ab0b0474f5e 61 fields · synced May 16, 2026
- EUDAMED c30d8632-ac16-409a-af58-6a9dbdeee1f4 61 fields · synced May 17, 2026
- EUDAMED b05d92e7-b0d4-482d-9537-d2b6e20f6a59 61 fields · synced May 17, 2026
- EUDAMED 7fd881d9-862d-43da-ac2d-21a13a17f64e 61 fields · synced May 18, 2026
- EUDAMED 95033408-4d9c-4539-bb7d-e3397780bf8d 61 fields · synced May 18, 2026
- EUDAMED 2da3285d-d3a5-4c8d-bf51-ecbd59f59c5d 61 fields · synced May 18, 2026
- EUDAMED f60dcc35-c6eb-4fc7-a840-3c7e83dc0827 61 fields · synced May 18, 2026
- EUDAMED b697434f-b51d-4015-96a5-f3f15b8bc7ef 61 fields · synced May 18, 2026